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Standard Versus Intensity-Modulated Pelvic Radiation Therapy in Treating Patients With Endometrial or Cervical Cancer

Primary Purpose

Cervical Cancer, Endometrial Cancer, Gastrointestinal Complications

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Standard radiation therapy
intensity-modulated radiation therapy
Sponsored by
Radiation Therapy Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring gastrointestinal complications, perioperative/postoperative complications, radiation toxicity, urinary complications, urinary tract toxicity, endometrial clear cell carcinoma, endometrial papillary serous carcinoma, stage IA endometrial carcinoma, stage IB endometrial carcinoma, stage II endometrial carcinoma, stage IIIA endometrial carcinoma, stage IIIB endometrial carcinoma, stage IIIC endometrial carcinoma, endometrial adenocarcinoma, cervical adenocarcinoma, stage IB cervical cancer, stage IIA cervical cancer, stage IIB cervical cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria:

  1. Pathologically proven diagnosis of endometrial or cervical cancer.
  2. Patients must have undergone a hysterectomy (total abdominal hysterectomy, vaginal hysterectomy or radical hysterectomy or total laparoscopic hysterectomy) for carcinoma of the cervix or endometrium within 49 days prior to registration. Performance of a bilateral salpingooophorectomy will be at the treating surgeon's discretion.
  3. Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:

    • 3.1 History/physical examination within 45 days prior to registration;
    • 3.2 CT, MRI or positron emission tomography - computed tomography (PET-CT) including the abdomen and pelvis should be performed for initial radiological staging. This may be performed pre- or post-surgery within 90 days prior to registration. Imaging performed post-operatively should show no evidence of residual disease. Any evidence of malignancy identified on pre-operative imaging should have been completely resected surgically prior to protocol treatment.
    • 3.3 Chest CT or chest x-ray must be performed within 90 days prior to registration (unless a PET-CT has been performed)
  4. Zubrod Performance Status 0-2
  5. Age ≥ 18;
  6. Complete blood count (CBC)/differential obtained within 14 days prior to registration on study, with adequate bone marrow function defined as follows:

    • 6.1 Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3;
    • 6.2 Platelets ≥ 100,000 cells/mm3;
    • 6.3 Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.)
  7. For patients receiving chemotherapy:

7.1 Within 14 days prior to registration, serum creatinine ≤ 1.5 mg/dL and calculated creatinine clearance ≥ 50 cc/min. Both tests must be within these limits. The creatinine clearance should be calculated using the Cockcroft-Gault formula: (See Section 7.3.1) 7.2 Aspartate aminotransferase (AST) ≤ 2 x upper limit of normal (ULN) 7.3 Bilirubin ≤ 2 x ULN 7.4 Alkaline phosphatase, Mg, blood urea nitrogen (BUN) and electrolytes must be obtained and recorded 8 Endometrial Cancer: 8.1 Patients with the following histologic features are eligible for pelvic radiation therapy without weekly cisplatin:

  • <50% myometrial invasion, grade 3 adenocarcinoma without uterine serous carcinoma (USC) or clear cell histology
  • ≥50% myometrial invasion grade 1-2 adenocarcinoma without USC or clear cell histology 8.2 Patients with the following histologic features may be treated with pelvic radiation with or without weekly cisplatin. The decision to add weekly cisplatin for these patients is at the treating physician's discretion:
  • ≥50% myometrial invasion, grade 3 including USC and clear cell carcinoma.
  • International Federation of Gynecology and Obstetrics (FIGO) 2009 stage II endometrial cancer of any grade including USC and clear cell carcinoma.
  • FIGO 2009 IIIC1 (pelvic lymph node positive only, para-aortic nodes negative if removed) including USC and clear cell carcinoma. Note: If para-aortic nodes are not removed, CT abdomen or PET CT must demonstrate no evidence of lymphadenopathy. 9. Cervical Cancer: 9.1 Patients with the following pathology findings may be treated with pelvic radiation with or without weekly cisplatin at the treating physician's discretion. The decision to add weekly cisplatin for these patients is at the treating physician's discretion. 9.1.1 Patients with intermediate risk features including two of the following histologic findings after radical hysterectomy:
  • 1/3 or more stromal invasion
  • Lymph-vascular space invasion
  • Large clinical tumor diameter (> 4 cm) 9.1.2 Patients with cervical cancer treated with a simple hysterectomy with negative margins 9.2 Patients with any of the following criteria following radical hysterectomy are eligible for this study and must receive weekly cisplatin:
  • Positive resected pelvic nodes and para-aortic nodes negative if removed. Note: If para-aortic nodes are not removed, CT abdomen or PET CT must demonstrate no evidence of lymphadenopathy.
  • Microscopic parametrial invasion with negative margins. 10. Patient must provide study specific informed consent prior to study entry. 11. Willingness and ability to complete the bowel and urinary domains of the EPIC prior to registration

Exclusion criteria:

  1. Patients with para-aortic nodal disease or who require extended field radiotherapy beyond the pelvis.
  2. Patients with histology consisting of endometrial stromal sarcoma, leiomyosarcoma or malignant mixed mullerian mixed tumor (MMMT or carcinosarcoma)
  3. Patients who exceed the weight/size limits of the treatment table or CT scanner.
  4. Mental status changes or bladder control problems that make the patient unable to comply with bladder-filling instructions.
  5. Patients with evidence of metastatic disease outside of the pelvis.
  6. Patients with positive or close (< 3 mm) resection margins
  7. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years.
  8. Prior radiation therapy to the pelvis
  9. Patients with active inflammatory bowel disease. 10 Severe, active co-morbidity, defined as follows:

    • 10.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
    • 10.2 Transmural myocardial infarction within the last 6 months
    • 10.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    • 10.4 Other major medical illness which requires hospitalization or precludes study therapy at the time of registration
    • 10.5 Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however,that laboratory test coagulation parameters are not required for entry into this protocol
    • 10.6 Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised patients.

11. Patients with prior treatment with platinum-based chemotherapy 12. Women who are breastfeeding

Sites / Locations

  • Banner MD Anderson Cancer Center
  • Arizona Oncology-Deer Valley Center
  • Arizona Oncology Services Foundation
  • California Cancer Center - North Fresno
  • UC San Diego Moores Cancer Center
  • Kaiser Permanente Oakland-Broadway
  • Saint Joseph Hospital - Orange
  • Feather River Cancer Center
  • Pomona Valley Hospital Medical Center
  • Kaiser Permanente-Rancho Cordova Cancer Center
  • Rohnert Park Cancer Center
  • The Permanente Medical Group-Roseville Radiation Oncology
  • University of California at Davis Cancer Center
  • South Sacramento Cancer Center
  • Kaiser Permanente Medical Center - Santa Clara
  • Kaiser Permanente Cancer Treatment Center
  • University of Colorado Cancer Center - Anschutz Cancer Pavilion
  • Penrose-Saint Francis Healthcare
  • Porter Adventist Hospital
  • Swedish Medical Center
  • Rocky Mountain Cancer Centers-Littleton
  • Longmont United Hospital
  • McKee Medical Center
  • Christiana Care Health System-Christiana Hospital
  • Beebe Health Campus
  • Washington Hospital Center
  • University of Florida
  • University of Florida Health Science Center
  • Jackson Memorial Hospital-Holtz Children's Hospital
  • University of Miami Miller School of Medicine-Sylvester Cancer Center
  • Grady Health System
  • Piedmont Hospital
  • Emory University/Winship Cancer Institute
  • Northside Hospital
  • Northside Hospital-Forsyth
  • Northeast Georgia Medical Center
  • Saint Joseph's-Candler Health System
  • Leeward Radiation Oncology Center
  • Queen's Medical Center
  • University of Hawaii
  • The Cancer Center of Hawaii-Liliha
  • Saint Alphonsus Cancer Care Center-Boise
  • Northwestern University
  • John H Stroger Jr Hospital of Cook County
  • University of Illinois
  • Advocate Illinois Masonic Medical Center
  • Ingalls Memorial Hospital
  • Saint Vincent Anderson Regional Hospital/Cancer Center
  • Franciscan Saint Margaret Health-Dyer Campus
  • Radiation Oncology Associates PC
  • Franciscan Saint Margaret Health-Hammond Campus
  • McFarland Clinic PC-William R Bliss Cancer Center
  • Mercy Cancer Center-West Lakes
  • Iowa Methodist Medical Center
  • Mercy Medical Center - Des Moines
  • Mary Bird Perkins Cancer Center
  • Ochsner Medical Center Jefferson
  • Greater Baltimore Medical Center
  • Sinai Hospital of Baltimore
  • Peninsula Regional Medical Center
  • Holy Cross Hospital
  • Brigham and Women's Hospital
  • Dana-Farber Cancer Institute
  • Boston Medical Center
  • Lowell General Hospital
  • Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
  • Dana-Farber/Brigham and Women's Cancer Center at South Shore
  • D'Amour Center for Cancer Care
  • Saint Joseph Mercy Hospital
  • Wayne State University/Karmanos Cancer Institute
  • Saint John Hospital and Medical Center
  • Mercy Health Saint Mary's
  • Spectrum Health at Butterworth Campus
  • Saint John Macomb-Oakland Hospital
  • Sanford Clinic North-Bemidgi
  • United Hospital
  • Ridgeview Medical Center
  • Saint John's Mercy Medical Center
  • Mercy Hospital Springfield
  • CoxHealth South Hospital
  • Billings Clinic
  • The Nebraska Medical Center
  • Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
  • Capital Health Medical Center-Hopewell
  • Virtua West Jersey Hospital Voorhees
  • University of New Mexico
  • Long Island Jewish Medical Center
  • North Shore-LIJ Health System/Center for Advanced Medicine
  • Stony Brook University Medical Center
  • South Atlantic Radiation Oncology
  • Coastal Carolina Radiation Oncology
  • New Hanover Regional Medical Center
  • Sanford Bismarck Medical Center
  • Summa Akron City Hospital/Cooper Cancer Center
  • Summa Barberton Hospital
  • Geaugra Hospital
  • Case Western Reserve University
  • The Mark H Zangmeister Center
  • Summa Health Center at Lake Medina
  • Lake University Ireland Cancer Center
  • Southwest General Health Center Ireland Cancer Center
  • UHHS-Chagrin Highlands Medical Center
  • Southern Ohio Medical Center
  • UHHS-Westlake Medical Center
  • University of Oklahoma Health Sciences Center
  • Abington Memorial Hospital
  • Paoli Memorial Hospital
  • Radiation Therapy Oncology Group
  • Mount Nittany Medical Center
  • Reading Hospital
  • Lankenau Hospital
  • Medical University of South Carolina
  • Self Regional Healthcare
  • Rapid City Regional Hospital
  • Sanford USD Medical Center - Sioux Falls
  • University of Texas Southwestern Medical Center
  • M D Anderson Cancer Center
  • University of Texas Health Science Center at San Antonio
  • Logan Regional Hospital
  • Intermountain Medical Center
  • Dixie Medical Center Regional Cancer Center
  • Huntsman Cancer Institute/University of Utah
  • LDS Hospital
  • Saint Francis Hospital
  • Virginia Mason CCOP
  • Edwards Comprehensive Cancer Center
  • Aurora BayCare Medical Center
  • Aurora Saint Luke's Medical Center
  • Aurora West Allis Medical Center
  • BCCA-Cancer Centre for the Southern Interior
  • BCCA-Vancouver Island Cancer Centre
  • Juravinski Cancer Centre at Hamilton Health Sciences
  • London Regional Cancer Program
  • Allan Blair Cancer Centre
  • Saskatoon Cancer Centre
  • Pamela Youde Nethersole Eastern Hospital
  • National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intensity-Modulated Radiation Therapy

Standard Radiation Therapy

Arm Description

intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy

Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy

Outcomes

Primary Outcome Measures

Acute Gastrointestinal Toxicity, as Measured by Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain Score at 5 Weeks From the Start of Pelvic Radiation
The primary endpoint is change in acute GI toxicity, as measured by the EPIC bowel domain, from baseline to 5 weeks after the first fraction of radiation is delivered. The EPIC has four domains (bowel, urinary, sexual, and hormonal) that have been validated separately, which allows use of only the domains of interest. The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). For each domain, responses form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, where higher scores correspond to better quality of life. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Change was calculated as follow-up score - baseline score so a negative change score indicates a decline in function.

Secondary Outcome Measures

Percentage of Patients With Acute Grade 2+ GI Toxicity at 5 Weeks From the Start of Treatment
Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Urinary Toxicity, as Measured by Change in EPIC Urinary Domain
The primary endpoint is change in acute GI toxicity, as measured by the EPIC urinary domain, from baseline to 5 weeks after the first fraction of radiation is delivered. The EPIC has four domains (bowel, urinary, sexual, and hormonal) that have been validated separately, which allows use of only the domains of interest. The EPIC urinary domain consists of 12 items and has a function subscale (5 items) and bother subscale (7 items). For each domain, responses form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, where higher scores correspond to better quality of life. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Change was calculated as follow-up score - baseline score so a negative change score indicates a decline in function.
Quality of Life, as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) and FACT-Cx (Cervix) Subscale
The FACT-G is a validated, 27-item measure where a higher score represents higher QOL. In addition to a total QOL score, subscale scores for physical, functional, social and emotional well-being are produced. There are 5 responses options, with 0=Not a lot and 4=Very much. All items in a subscale are added together to obtain subscale totals. Scores range from 0-108 for the FACT-G total score, 0-28 for physical, social, functional, and 0-24 for emotional subscale. Certain items must be reversed before it is added by subtracting the response from 4. Subscale totals are summed to form the FACT-G total score. The FACT-Cx is 5-items, with score ranging 0-60, but is not included in total FACT-G. Each subscale requires >= 50% of items completed and overall response rate must be greater than 80%. If items are missing, the subscale scores can be prorated. Change calculated as follow-up score - baseline score so that a negative change score indicates a decline in function.
Health Utilities, as Measured by Change From Baseline in EQ-5D
The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Both the 5-item index score and the VAS score are transformed into a utility score between 0 (worst health state) and 1 (best health state). Change from baseline is calculated as score at the timepoint of interested - baseline score.
Local-regional Recurrence
Local recurrence is defined as a disease in the radiation treatment field. This can include a local vaginal recurrence or nodal disease within the field. Para-aortic recurrence is defined as new lymphadenopathy in the para-aortic distribution. Local-regional control time is defined as time from randomization to the date of local recurrence, last known follow-up (censored), or death (competing risk). Local-regional recurrence rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year rates are provided. Analysis occurred after all patients had been on study for at least 3 years.
Disease-free Survival
Disease (progression) is defined as local recurrence, para-aortic recurrence, or distant metastasis. Local recurrence is defined as a disease in the radiation treatment field. Para-aortic recurrence is defined as new lymphadenopathy in the para-aortic distribution. Distant metastasis is defined as involvement of another organ or peritoneal disease. Disease-free survival time is defined as time from randomization to the date of progression, death, or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year rates are provided. Analysis occurred after all patients had been on study for at least 3 years.
Overall Survival
Overall survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year rates are provided. Analysis occurred after all patients had been on study for at least 3 years.
Identification of Molecular Predictors of Radiation Toxicity and Novel Circulating Cancer Biomarkers
Standardized Cronbach's Alpha for EPIC Bowel and Urinary Domains (Validation - Internal Consistency Reliability)
The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). The EPIC urinary domain consists of 12 total items and 4 subscales, functional (5 items), bother (7), incontinence (4) and irritative/obstructive (7). For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life. A domain score is the average of the transformed item scores. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Cronbach's alpha is an internal consistency estimate of reliability of psychometric test scores and is a function of the number of items in a test, the average covariance between item-pairs, and the variance of the total score. An alpha of 0.60-0.79 was to be considered acceptable reliability; higher than 0.8 was to be considered good reliability.
Spearman's Correlation Coefficient for EPIC Bowel Domain vs. Urinary Domains (Validation - Conceptual Independence)
The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). The EPIC urinary domain consists of 12 total items and 4 subscales, functional (5 items), bother (7), incontinence (4) and irritative/obstructive (7). For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life. A domain score is the average of the transformed item scores. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Spearman's rank correlation coefficient is a nonparametric measure of rank correlation between two variables with a value between +1 and -1, where 1 is total positive rank correlation, 0 is no rank correlation, and -1 is total negative rank correlation.
Pearson Correlation Coefficient for EPIC Bowel and Urinary Domains vs. FACT-G Total Score (Validation - Criterion Validity)
The EPIC bowel domain and urinary domains consist of 14 and 12 items, respectively. For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life (QOL). A domain score is the average of the transformed item scores. At least 80% of the items in a domain must be completed in order to compute the score. The FACT-G is 27-item measure. Higher scores represent higher QOL. Each item has 5 responses options, 0=Not a lot and 4=Very much. Items are added together for the total score, ranging from 0-108. Certain items must be reversed before adding by subtracting the response from 4. The Pearson correlation coefficient is a measure of the linear correlation between two variables with a value between +1 and -1, where 1 is total positive linear correlation, 0 is no linear correlation, and -1 is total negative linear correlation.
Mean Change From Baseline in EPIC Bowel and Urinary Domain (Validation - Sensitivity to Treatment)
The EPIC bowel domain and urinary domains consist of 14 and 12 items, respectively. For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life (QOL). A domain score is the average of the transformed item scores. At least 80% of the items in a domain must be completed in order to compute the score. Difference is calculated as baseline - week 5. A positive change score represents a decline in function.

Full Information

First Posted
August 23, 2012
Last Updated
May 23, 2022
Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI), NRG Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT01672892
Brief Title
Standard Versus Intensity-Modulated Pelvic Radiation Therapy in Treating Patients With Endometrial or Cervical Cancer
Official Title
A Randomized Phase III Study of Standard vs. IMRT Pelvic Radiation for Post-Operative Treatment of Endometrial and Cervical Cancer (TIME-C)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
May 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI), NRG Oncology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This randomized phase III trial is studying two different methods of radiation and their side effects and comparing how well they work in treating endometrial and cervical cancer after surgery.
Detailed Description
OBJECTIVES: Primary To determine if pelvic intensity-modulated radiation therapy (IMRT) reduces acute gastrointestinal toxicity in the 5th week (after 23-25 fractions) of pelvic radiation as measured with the expanded prostate cancer index composite (EPIC) instrument. Secondary To determine if grade 2+ gastrointestinal toxicity (Common Terminology Criteria for Adverse Events version 4.0 [CTCAE v. 4.0]) is reduced with IMRT compared to conventional whole-pelvis radiation therapy (WPRT). To determine if grade 2+ hematologic toxicity (CTCAE v. 4.0) is reduced with IMRT compared to conventional WPRT. To determine if urinary toxicity is reduced with IMRT using the EPIC urinary domain. To validate EPIC bowel and urinary domains in women undergoing either IMRT pelvic radiation treatment or four-field pelvic radiation treatment for endometrial or cervical cancer. To assess the impact of pelvic IMRT on quality of life using the Functional Assessment of Cancer Therapy-General (FACT-G) with cervix subscale. To determine if there is any difference in local-regional control, disease-free survival, and overall survival between patients treated with IMRT as compared to conventional WPRT. To perform a health-utilities analysis to measure the financial impact of pelvic IMRT via the EQ-5D instrument. To identify molecular predictors of radiation toxicity and novel circulating cancer biomarkers. OUTLINE: This is a multicenter study. Patients are stratified according to type of cancer (endometrial vs cervical), chemotherapy (none vs 5 courses of weekly cisplatin at 40 mg/m²), and radiation dose (45 Gy vs 50.4 Gy). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo standard (3-dimensional) radiation therapy 5 days a week for up to 5-6 weeks. Arm II: Patients undergo intensity-modulated radiation therapy (IMRT) 5 days a week for up to 5-6 weeks. Some patients receive cisplatin IV over 1 hour on day 1. Treatment continues weekly for 5 weeks, concurrently with radiation therapy, in the absence of unacceptable toxicity or disease progression. Tissue and blood samples may be collected for biomarker and correlative analysis. Quality of life may be assessed by questionnaires (including the Expanded Prostate Cancer Index Composite [EPIC], the Functional Assessment of Cancer Therapy-General [FACT-G, Version 4], the EQ-5D, and the Common Toxicity Criteria Adverse Events - Patient-Reported Outcome [PRO-CTCAE]) instruments at baseline and periodically during and after study therapy. After completion of study therapy, patients are followed every 6 months for the first 2 years and then annually for 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Endometrial Cancer, Gastrointestinal Complications, Perioperative/Postoperative Complications, Radiation Toxicity, Urinary Complications, Urinary Tract Toxicity
Keywords
gastrointestinal complications, perioperative/postoperative complications, radiation toxicity, urinary complications, urinary tract toxicity, endometrial clear cell carcinoma, endometrial papillary serous carcinoma, stage IA endometrial carcinoma, stage IB endometrial carcinoma, stage II endometrial carcinoma, stage IIIA endometrial carcinoma, stage IIIB endometrial carcinoma, stage IIIC endometrial carcinoma, endometrial adenocarcinoma, cervical adenocarcinoma, stage IB cervical cancer, stage IIA cervical cancer, stage IIB cervical cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
289 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensity-Modulated Radiation Therapy
Arm Type
Experimental
Arm Description
intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy
Arm Title
Standard Radiation Therapy
Arm Type
Active Comparator
Arm Description
Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
Intervention Type
Radiation
Intervention Name(s)
Standard radiation therapy
Other Intervention Name(s)
RT
Intervention Description
Patients treated once a day, 5 days a week with a daily fraction size of 1.8 Gy. Whole pelvis treated with a four-field technique (AP/PA/R lateral/L lateral) to 45 or 50.4 Gy at 1.8 Gy/fraction. The dose is prescribed to the isocenter which is defined as the intersection of the four beams and can be normalized to an isodose line between 97-100%. The decision to deliver 45 or 50.4 Gy is at the physician's discretion and must be reported at the time of enrollment.
Intervention Type
Radiation
Intervention Name(s)
intensity-modulated radiation therapy
Other Intervention Name(s)
IMRT
Intervention Description
Patients treated once a day, 5 days a week with a daily fraction size of 1.8 Gy. All targets treated simultaneously. The vaginal planning target volume (PTV) (ITV with 7.0 mm margin) and nodal PTV receives 45 Gy in 25 fractions or 50.4 Gy in 28 fractions. The decision to deliver 45 or 50.4 Gy is at the physician's discretion and must be reported at the time of enrollment.
Primary Outcome Measure Information:
Title
Acute Gastrointestinal Toxicity, as Measured by Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain Score at 5 Weeks From the Start of Pelvic Radiation
Description
The primary endpoint is change in acute GI toxicity, as measured by the EPIC bowel domain, from baseline to 5 weeks after the first fraction of radiation is delivered. The EPIC has four domains (bowel, urinary, sexual, and hormonal) that have been validated separately, which allows use of only the domains of interest. The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). For each domain, responses form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, where higher scores correspond to better quality of life. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Change was calculated as follow-up score - baseline score so a negative change score indicates a decline in function.
Time Frame
Baseline and week 5 of RT
Secondary Outcome Measure Information:
Title
Percentage of Patients With Acute Grade 2+ GI Toxicity at 5 Weeks From the Start of Treatment
Description
Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Time Frame
Baseline to Week 5 of RT
Title
Urinary Toxicity, as Measured by Change in EPIC Urinary Domain
Description
The primary endpoint is change in acute GI toxicity, as measured by the EPIC urinary domain, from baseline to 5 weeks after the first fraction of radiation is delivered. The EPIC has four domains (bowel, urinary, sexual, and hormonal) that have been validated separately, which allows use of only the domains of interest. The EPIC urinary domain consists of 12 items and has a function subscale (5 items) and bother subscale (7 items). For each domain, responses form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, where higher scores correspond to better quality of life. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Change was calculated as follow-up score - baseline score so a negative change score indicates a decline in function.
Time Frame
Baseline, week 3 and 5 of RT, and 4-6 weeks after RT
Title
Quality of Life, as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) and FACT-Cx (Cervix) Subscale
Description
The FACT-G is a validated, 27-item measure where a higher score represents higher QOL. In addition to a total QOL score, subscale scores for physical, functional, social and emotional well-being are produced. There are 5 responses options, with 0=Not a lot and 4=Very much. All items in a subscale are added together to obtain subscale totals. Scores range from 0-108 for the FACT-G total score, 0-28 for physical, social, functional, and 0-24 for emotional subscale. Certain items must be reversed before it is added by subtracting the response from 4. Subscale totals are summed to form the FACT-G total score. The FACT-Cx is 5-items, with score ranging 0-60, but is not included in total FACT-G. Each subscale requires >= 50% of items completed and overall response rate must be greater than 80%. If items are missing, the subscale scores can be prorated. Change calculated as follow-up score - baseline score so that a negative change score indicates a decline in function.
Time Frame
Before study start, Week 5 of RT, 4-6 Weeks after RT, 1 year from start of RT and 3 years from start of RT
Title
Health Utilities, as Measured by Change From Baseline in EQ-5D
Description
The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Both the 5-item index score and the VAS score are transformed into a utility score between 0 (worst health state) and 1 (best health state). Change from baseline is calculated as score at the timepoint of interested - baseline score.
Time Frame
Baseline, week 5 of RT, 4-6 weeks after RT
Title
Local-regional Recurrence
Description
Local recurrence is defined as a disease in the radiation treatment field. This can include a local vaginal recurrence or nodal disease within the field. Para-aortic recurrence is defined as new lymphadenopathy in the para-aortic distribution. Local-regional control time is defined as time from randomization to the date of local recurrence, last known follow-up (censored), or death (competing risk). Local-regional recurrence rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year rates are provided. Analysis occurred after all patients had been on study for at least 3 years.
Time Frame
From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months.
Title
Disease-free Survival
Description
Disease (progression) is defined as local recurrence, para-aortic recurrence, or distant metastasis. Local recurrence is defined as a disease in the radiation treatment field. Para-aortic recurrence is defined as new lymphadenopathy in the para-aortic distribution. Distant metastasis is defined as involvement of another organ or peritoneal disease. Disease-free survival time is defined as time from randomization to the date of progression, death, or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year rates are provided. Analysis occurred after all patients had been on study for at least 3 years.
Time Frame
From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months.
Title
Overall Survival
Description
Overall survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year rates are provided. Analysis occurred after all patients had been on study for at least 3 years.
Time Frame
From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months.
Title
Identification of Molecular Predictors of Radiation Toxicity and Novel Circulating Cancer Biomarkers
Time Frame
Outcome measure will not be analyzed
Title
Standardized Cronbach's Alpha for EPIC Bowel and Urinary Domains (Validation - Internal Consistency Reliability)
Description
The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). The EPIC urinary domain consists of 12 total items and 4 subscales, functional (5 items), bother (7), incontinence (4) and irritative/obstructive (7). For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life. A domain score is the average of the transformed item scores. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Cronbach's alpha is an internal consistency estimate of reliability of psychometric test scores and is a function of the number of items in a test, the average covariance between item-pairs, and the variance of the total score. An alpha of 0.60-0.79 was to be considered acceptable reliability; higher than 0.8 was to be considered good reliability.
Time Frame
Baseline and week 5 of RT
Title
Spearman's Correlation Coefficient for EPIC Bowel Domain vs. Urinary Domains (Validation - Conceptual Independence)
Description
The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). The EPIC urinary domain consists of 12 total items and 4 subscales, functional (5 items), bother (7), incontinence (4) and irritative/obstructive (7). For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life. A domain score is the average of the transformed item scores. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Spearman's rank correlation coefficient is a nonparametric measure of rank correlation between two variables with a value between +1 and -1, where 1 is total positive rank correlation, 0 is no rank correlation, and -1 is total negative rank correlation.
Time Frame
Baseline and week 5 of RT
Title
Pearson Correlation Coefficient for EPIC Bowel and Urinary Domains vs. FACT-G Total Score (Validation - Criterion Validity)
Description
The EPIC bowel domain and urinary domains consist of 14 and 12 items, respectively. For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life (QOL). A domain score is the average of the transformed item scores. At least 80% of the items in a domain must be completed in order to compute the score. The FACT-G is 27-item measure. Higher scores represent higher QOL. Each item has 5 responses options, 0=Not a lot and 4=Very much. Items are added together for the total score, ranging from 0-108. Certain items must be reversed before adding by subtracting the response from 4. The Pearson correlation coefficient is a measure of the linear correlation between two variables with a value between +1 and -1, where 1 is total positive linear correlation, 0 is no linear correlation, and -1 is total negative linear correlation.
Time Frame
Baseline and week 5 of RT
Title
Mean Change From Baseline in EPIC Bowel and Urinary Domain (Validation - Sensitivity to Treatment)
Description
The EPIC bowel domain and urinary domains consist of 14 and 12 items, respectively. For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life (QOL). A domain score is the average of the transformed item scores. At least 80% of the items in a domain must be completed in order to compute the score. Difference is calculated as baseline - week 5. A positive change score represents a decline in function.
Time Frame
Baseline and week 5 of RT

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Pathologically proven diagnosis of endometrial or cervical cancer. Patients must have undergone a hysterectomy (total abdominal hysterectomy, vaginal hysterectomy or radical hysterectomy or total laparoscopic hysterectomy) for carcinoma of the cervix or endometrium within 49 days prior to registration. Performance of a bilateral salpingooophorectomy will be at the treating surgeon's discretion. Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup: 3.1 History/physical examination within 45 days prior to registration; 3.2 CT, MRI or positron emission tomography - computed tomography (PET-CT) including the abdomen and pelvis should be performed for initial radiological staging. This may be performed pre- or post-surgery within 90 days prior to registration. Imaging performed post-operatively should show no evidence of residual disease. Any evidence of malignancy identified on pre-operative imaging should have been completely resected surgically prior to protocol treatment. 3.3 Chest CT or chest x-ray must be performed within 90 days prior to registration (unless a PET-CT has been performed) Zubrod Performance Status 0-2 Age ≥ 18; Complete blood count (CBC)/differential obtained within 14 days prior to registration on study, with adequate bone marrow function defined as follows: 6.1 Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; 6.2 Platelets ≥ 100,000 cells/mm3; 6.3 Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.) For patients receiving chemotherapy: 7.1 Within 14 days prior to registration, serum creatinine ≤ 1.5 mg/dL and calculated creatinine clearance ≥ 50 cc/min. Both tests must be within these limits. The creatinine clearance should be calculated using the Cockcroft-Gault formula: (See Section 7.3.1) 7.2 Aspartate aminotransferase (AST) ≤ 2 x upper limit of normal (ULN) 7.3 Bilirubin ≤ 2 x ULN 7.4 Alkaline phosphatase, Mg, blood urea nitrogen (BUN) and electrolytes must be obtained and recorded 8 Endometrial Cancer: 8.1 Patients with the following histologic features are eligible for pelvic radiation therapy without weekly cisplatin: <50% myometrial invasion, grade 3 adenocarcinoma without uterine serous carcinoma (USC) or clear cell histology ≥50% myometrial invasion grade 1-2 adenocarcinoma without USC or clear cell histology 8.2 Patients with the following histologic features may be treated with pelvic radiation with or without weekly cisplatin. The decision to add weekly cisplatin for these patients is at the treating physician's discretion: ≥50% myometrial invasion, grade 3 including USC and clear cell carcinoma. International Federation of Gynecology and Obstetrics (FIGO) 2009 stage II endometrial cancer of any grade including USC and clear cell carcinoma. FIGO 2009 IIIC1 (pelvic lymph node positive only, para-aortic nodes negative if removed) including USC and clear cell carcinoma. Note: If para-aortic nodes are not removed, CT abdomen or PET CT must demonstrate no evidence of lymphadenopathy. 9. Cervical Cancer: 9.1 Patients with the following pathology findings may be treated with pelvic radiation with or without weekly cisplatin at the treating physician's discretion. The decision to add weekly cisplatin for these patients is at the treating physician's discretion. 9.1.1 Patients with intermediate risk features including two of the following histologic findings after radical hysterectomy: 1/3 or more stromal invasion Lymph-vascular space invasion Large clinical tumor diameter (> 4 cm) 9.1.2 Patients with cervical cancer treated with a simple hysterectomy with negative margins 9.2 Patients with any of the following criteria following radical hysterectomy are eligible for this study and must receive weekly cisplatin: Positive resected pelvic nodes and para-aortic nodes negative if removed. Note: If para-aortic nodes are not removed, CT abdomen or PET CT must demonstrate no evidence of lymphadenopathy. Microscopic parametrial invasion with negative margins. 10. Patient must provide study specific informed consent prior to study entry. 11. Willingness and ability to complete the bowel and urinary domains of the EPIC prior to registration Exclusion criteria: Patients with para-aortic nodal disease or who require extended field radiotherapy beyond the pelvis. Patients with histology consisting of endometrial stromal sarcoma, leiomyosarcoma or malignant mixed mullerian mixed tumor (MMMT or carcinosarcoma) Patients who exceed the weight/size limits of the treatment table or CT scanner. Mental status changes or bladder control problems that make the patient unable to comply with bladder-filling instructions. Patients with evidence of metastatic disease outside of the pelvis. Patients with positive or close (< 3 mm) resection margins Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years. Prior radiation therapy to the pelvis Patients with active inflammatory bowel disease. 10 Severe, active co-morbidity, defined as follows: 10.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months 10.2 Transmural myocardial infarction within the last 6 months 10.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration 10.4 Other major medical illness which requires hospitalization or precludes study therapy at the time of registration 10.5 Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however,that laboratory test coagulation parameters are not required for entry into this protocol 10.6 Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised patients. 11. Patients with prior treatment with platinum-based chemotherapy 12. Women who are breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Klopp, MD, PhD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Arizona Oncology-Deer Valley Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85027
Country
United States
Facility Name
Arizona Oncology Services Foundation
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
California Cancer Center - North Fresno
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Kaiser Permanente Oakland-Broadway
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
Saint Joseph Hospital - Orange
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Feather River Cancer Center
City
Paradise
State/Province
California
ZIP/Postal Code
95969
Country
United States
Facility Name
Pomona Valley Hospital Medical Center
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Kaiser Permanente-Rancho Cordova Cancer Center
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Rohnert Park Cancer Center
City
Rohnert Park
State/Province
California
ZIP/Postal Code
94928
Country
United States
Facility Name
The Permanente Medical Group-Roseville Radiation Oncology
City
Roseville
State/Province
California
ZIP/Postal Code
95678
Country
United States
Facility Name
University of California at Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
South Sacramento Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Facility Name
Kaiser Permanente Medical Center - Santa Clara
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
Facility Name
Kaiser Permanente Cancer Treatment Center
City
South San Francisco
State/Province
California
ZIP/Postal Code
94080
Country
United States
Facility Name
University of Colorado Cancer Center - Anschutz Cancer Pavilion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Penrose-Saint Francis Healthcare
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Porter Adventist Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Swedish Medical Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Rocky Mountain Cancer Centers-Littleton
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Longmont United Hospital
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
McKee Medical Center
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80539
Country
United States
Facility Name
Christiana Care Health System-Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Beebe Health Campus
City
Rehoboth Beach
State/Province
Delaware
ZIP/Postal Code
19971
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University of Florida Health Science Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Jackson Memorial Hospital-Holtz Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Miami Miller School of Medicine-Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Grady Health System
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Emory University/Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Northside Hospital-Forsyth
City
Cumming
State/Province
Georgia
ZIP/Postal Code
30041
Country
United States
Facility Name
Northeast Georgia Medical Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Saint Joseph's-Candler Health System
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Leeward Radiation Oncology Center
City
'Ewa Beach
State/Province
Hawaii
ZIP/Postal Code
96706
Country
United States
Facility Name
Queen's Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
University of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
The Cancer Center of Hawaii-Liliha
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Saint Alphonsus Cancer Care Center-Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
John H Stroger Jr Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-3785
Country
United States
Facility Name
University of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Advocate Illinois Masonic Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Saint Vincent Anderson Regional Hospital/Cancer Center
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46016
Country
United States
Facility Name
Franciscan Saint Margaret Health-Dyer Campus
City
Dyer
State/Province
Indiana
ZIP/Postal Code
46311
Country
United States
Facility Name
Radiation Oncology Associates PC
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Franciscan Saint Margaret Health-Hammond Campus
City
Hammond
State/Province
Indiana
ZIP/Postal Code
46320
Country
United States
Facility Name
McFarland Clinic PC-William R Bliss Cancer Center
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
Mercy Cancer Center-West Lakes
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Mercy Medical Center - Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Mary Bird Perkins Cancer Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Ochsner Medical Center Jefferson
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Greater Baltimore Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Peninsula Regional Medical Center
City
Salisbury
State/Province
Maryland
ZIP/Postal Code
21801
Country
United States
Facility Name
Holy Cross Hospital
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Lowell General Hospital
City
Lowell
State/Province
Massachusetts
ZIP/Postal Code
01854
Country
United States
Facility Name
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
City
Milford
State/Province
Massachusetts
ZIP/Postal Code
01757
Country
United States
Facility Name
Dana-Farber/Brigham and Women's Cancer Center at South Shore
City
South Weymouth
State/Province
Massachusetts
ZIP/Postal Code
02190
Country
United States
Facility Name
D'Amour Center for Cancer Care
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Saint Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106-0995
Country
United States
Facility Name
Wayne State University/Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Saint John Hospital and Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Mercy Health Saint Mary's
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Spectrum Health at Butterworth Campus
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Saint John Macomb-Oakland Hospital
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Facility Name
Sanford Clinic North-Bemidgi
City
Bemidji
State/Province
Minnesota
ZIP/Postal Code
56601
Country
United States
Facility Name
United Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Ridgeview Medical Center
City
Waconia
State/Province
Minnesota
ZIP/Postal Code
55387
Country
United States
Facility Name
Saint John's Mercy Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Mercy Hospital Springfield
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
CoxHealth South Hospital
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Billings Clinic
City
Billings
State/Province
Montana
ZIP/Postal Code
59107-7000
Country
United States
Facility Name
The Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
City
Mount Holly
State/Province
New Jersey
ZIP/Postal Code
08060
Country
United States
Facility Name
Capital Health Medical Center-Hopewell
City
Pennington
State/Province
New Jersey
ZIP/Postal Code
08534
Country
United States
Facility Name
Virtua West Jersey Hospital Voorhees
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
North Shore-LIJ Health System/Center for Advanced Medicine
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
South Atlantic Radiation Oncology
City
Supply
State/Province
North Carolina
ZIP/Postal Code
28462
Country
United States
Facility Name
Coastal Carolina Radiation Oncology
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
New Hanover Regional Medical Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Sanford Bismarck Medical Center
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Summa Akron City Hospital/Cooper Cancer Center
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
Summa Barberton Hospital
City
Barberton
State/Province
Ohio
ZIP/Postal Code
44203
Country
United States
Facility Name
Geaugra Hospital
City
Chardon
State/Province
Ohio
ZIP/Postal Code
44024
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
The Mark H Zangmeister Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Facility Name
Summa Health Center at Lake Medina
City
Medina
State/Province
Ohio
ZIP/Postal Code
44256
Country
United States
Facility Name
Lake University Ireland Cancer Center
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Southwest General Health Center Ireland Cancer Center
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
UHHS-Chagrin Highlands Medical Center
City
Orange Village
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Southern Ohio Medical Center
City
Portsmouth
State/Province
Ohio
ZIP/Postal Code
45662
Country
United States
Facility Name
UHHS-Westlake Medical Center
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Paoli Memorial Hospital
City
Paoli
State/Province
Pennsylvania
ZIP/Postal Code
19301
Country
United States
Facility Name
Radiation Therapy Oncology Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Mount Nittany Medical Center
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16803
Country
United States
Facility Name
Reading Hospital
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Lankenau Hospital
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Self Regional Healthcare
City
Greenwood
State/Province
South Carolina
ZIP/Postal Code
29646
Country
United States
Facility Name
Rapid City Regional Hospital
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Sanford USD Medical Center - Sioux Falls
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5134
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Logan Regional Hospital
City
Logan
State/Province
Utah
ZIP/Postal Code
84321
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84157
Country
United States
Facility Name
Dixie Medical Center Regional Cancer Center
City
Saint George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
Facility Name
Huntsman Cancer Institute/University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Saint Francis Hospital
City
Federal Way
State/Province
Washington
ZIP/Postal Code
98003
Country
United States
Facility Name
Virginia Mason CCOP
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Edwards Comprehensive Cancer Center
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
Aurora BayCare Medical Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54311-6519
Country
United States
Facility Name
Aurora Saint Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Aurora West Allis Medical Center
City
West Allis
State/Province
Wisconsin
ZIP/Postal Code
53227
Country
United States
Facility Name
BCCA-Cancer Centre for the Southern Interior
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
BCCA-Vancouver Island Cancer Centre
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6V5
Country
Canada
Facility Name
Juravinski Cancer Centre at Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
London Regional Cancer Program
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Allan Blair Cancer Centre
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada
Facility Name
Saskatoon Cancer Centre
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
Pamela Youde Nethersole Eastern Hospital
City
Chai Wan
Country
Hong Kong
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore

12. IPD Sharing Statement

Citations:
PubMed Identifier
32073955
Citation
Yeung AR, Pugh SL, Klopp AH, Gil KM, Wenzel L, Westin SN, Gaffney DK, Small W Jr, Thompson S, Doncals DE, Cantuaria GHC, Yaremko BP, Chang A, Kundapur V, Mohan DS, Haas ML, Kim YB, Ferguson CL, Deshmukh S, Bruner DW, Kachnic LA. Improvement in Patient-Reported Outcomes With Intensity-Modulated Radiotherapy (RT) Compared With Standard RT: A Report From the NRG Oncology RTOG 1203 Study. J Clin Oncol. 2020 May 20;38(15):1685-1692. doi: 10.1200/JCO.19.02381. Epub 2020 Feb 19.
Results Reference
background
PubMed Identifier
31104905
Citation
Gil KM, Pugh SL, Klopp AH, Yeung AR, Wenzel L, Westin SN, Gaffney DK, Small W Jr, Thompson S, Doncals DE, Cantuaria GHC, Yaremko BP, Chang A, Kundapur V, Mohan DS, Haas ML, Kim YB, Ferguson CL, Deshmukh S, Kachnic LA, Bruner DW. Expanded validation of the EPIC bowel and urinary domains for use in women with gynecologic cancer undergoing postoperative radiotherapy. Gynecol Oncol. 2019 Jul;154(1):183-188. doi: 10.1016/j.ygyno.2019.04.682. Epub 2019 May 16.
Results Reference
result
PubMed Identifier
29989857
Citation
Klopp AH, Yeung AR, Deshmukh S, Gil KM, Wenzel L, Westin SN, Gifford K, Gaffney DK, Small W Jr, Thompson S, Doncals DE, Cantuaria GHC, Yaremko BP, Chang A, Kundapur V, Mohan DS, Haas ML, Kim YB, Ferguson CL, Pugh SL, Kachnic LA, Bruner DW. Patient-Reported Toxicity During Pelvic Intensity-Modulated Radiation Therapy: NRG Oncology-RTOG 1203. J Clin Oncol. 2018 Aug 20;36(24):2538-2544. doi: 10.1200/JCO.2017.77.4273. Epub 2018 Jul 10. Erratum In: J Clin Oncol. 2019 Mar 20;37(9):761. J Clin Oncol. 2020 Apr 1;38(10):1118.
Results Reference
result
PubMed Identifier
35960897
Citation
Yeung AR, Deshmukh S, Klopp AH, Gil KM, Wenzel L, Westin SN, Konski AA, Gaffney DK, Small W Jr, Thompson JS, Doncals DE, Cantuaria GHC, D'Souza DP, Chang A, Kundapur V, Mohan DS, Haas ML, Kim YB, Ferguson CL, Pugh SL, Kachnic LA, Bruner DW. Intensity-Modulated Radiation Therapy Reduces Patient-Reported Chronic Toxicity Compared With Conventional Pelvic Radiation Therapy: Updated Results of a Phase III Trial. J Clin Oncol. 2022 Sep 20;40(27):3115-3119. doi: 10.1200/JCO.21.02831. Epub 2022 Aug 12.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://nctn-data-archive.nci.nih.gov/
Available IPD/Information Identifier
NCT01672892-D1
Available IPD/Information Comments
Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.

Learn more about this trial

Standard Versus Intensity-Modulated Pelvic Radiation Therapy in Treating Patients With Endometrial or Cervical Cancer

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