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Combination Chemotherapy and Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
capecitabine
oxaliplatin
resection
radiation therapy
FOLFOX
Sponsored by
Radiation Therapy Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage III rectal cancer, adenocarcinoma of the rectum

Eligibility Criteria

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

DISEASE CHARACTERISTICS:

  • Pathologically confirmed diagnosis of adenocarcinoma of the rectum by biopsy technique that does not completely excise the lesion (e.g., fine needle aspiration, core needle biopsy)

    • Located up to 12 cm from the anal verge with no extension of malignant disease into the anal canal

    • Clinically determined to be stage T3 or T4,N0-N2, and M0 tumor as determined by the following assessments:

      • Colonoscopy and biopsy within 56 days prior to registration
      • History/physical examination (including medication history screen for contraindications) within 56 days prior to registration
      • Contrast-enhanced imaging of the abdomen and pelvis either by computed tomography(CT), MRI, or Positron-emission tomography(PET)-CT (whole body preferred) within 56 days prior to registration
      • Chest x-ray (or CT) of the chest within within 56 days prior to registration to exclude distant metastases (except for patients who have had whole body PET-CT)

      • Transrectal ultrasound (TRUS) within 56 days prior to registration required to establish tumor stage

        • TRUS not required if clinical exam, CT of the pelvis, and/or MRI demonstrates T4 lesion
  • No synchronous primary colon carcinoma
  • No evidence of distant metastases (M1)

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • Zubrod performance status 0-2
  • Absolute neutrophil count (ANC) ≥ 1,800/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve hemoglobin ≥ 8.0 g/dL allowed)
  • Aspartate aminotransferase (AST) < 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase < 2.5 times ULN
  • Bilirubin ≤ 1.5 times ULN
  • Creatinine clearance > 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior invasive malignancy except nonmelanoma skin cancer unless disease free for a minimum of 3 years

Exclusion criteria:

  • Severe, active comorbidity, defined as follows:

    • Unstable angina and/or congestive heart failure requiring hospitalization within the past 12 months
    • Transmural myocardial infarction within the past 6 months
    • Acute bacterial or fungal infection requiring intravenous antibiotics
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within the past 30 days
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
    • AIDS
    • Evidence of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake
    • Known, existing uncontrolled coagulopathy, unless clinically stable on anticoagulation therapy for ≥ 2 weeks
    • Evidence of peripheral neuropathy ≥ grade 2
  • Prior allergic reaction to oxaliplatin or capecitabine
  • Lack of physical integrity of the gastrointestinal tract (i.e., severe Crohn disease that results in malabsorption; significant bowel resection that would make one concerned about the absorption of capecitabine) or malabsorption syndrome that would preclude feasibility of oral chemotherapy (i.e., capecitabine)
  • Prior systemic chemotherapy for colorectal cancer (prior chemotherapy allowed provided it was for a cancer other than colorectal cancer)
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
  • Major surgery within 28 days of study enrollment(other than diverting colostomy without tumor resection)
  • Participation in any investigational drug study within 28 days of study enrollment.
  • Concurrent cimetidine, amifostine, and/or depot Sandostatin

Sites / Locations

  • Providence Cancer Center at Providence Hospital
  • Auburn Radiation Oncology
  • Radiation Oncology Centers - Cameron Park
  • Mercy Cancer Center at Mercy San Juan Medical Center
  • City of Hope Comprehensive Cancer Center
  • California Cancer Center - Woodward Park Office
  • Rebecca and John Moores UCSD Cancer Center
  • Radiation Oncology Center - Roseville
  • Radiological Associates of Sacramento Medical Group, Incorporated
  • Mercy General Hospital
  • Veterans Affairs Medical Center - San Diego
  • Solano Radiation Oncology Center
  • Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
  • University of Florida Shands Cancer Center
  • Baptist Cancer Institute - Jacksonville
  • Baptist-South Miami Regional Cancer Program
  • Integrated Community Oncology Network - Orange Park
  • Bay Medical
  • Piedmont Hospital
  • John B. Amos Cancer Center
  • Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
  • Cancer Institute at St. John's Hospital
  • Saint John's Cancer Center at Saint John's Medical Center
  • Center for Cancer Care at Goshen General Hospital
  • St. Vincent Oncology Center
  • Cancer Center at Ball Memorial Hospital
  • Menorah Medical Center
  • Saint Luke's Hospital - South
  • Shawnee Mission Medical Center
  • Greenebaum Cancer Center at University of Maryland Medical Center
  • Massachusetts General Hospital
  • Dana-Farber/Brigham and Women's Cancer Center
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  • Boston University Cancer Research Center
  • Hudner Oncology Center at Saint Anne's Hospital - Fall River
  • Fairview Ridges Hospital
  • Mercy and Unity Cancer Center at Mercy Hospital
  • Fairview Southdale Hospital
  • Mercy and Unity Cancer Center at Unity Hospital
  • Minnesota Oncology Hematology, PA - Maplewood
  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
  • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
  • CCOP - Metro-Minnesota
  • Park Nicollet Cancer Center
  • United Hospital
  • St. Francis Cancer Center at St. Francis Medical Center
  • Ridgeview Medical Center
  • Minnesota Oncology Hematology, PA - Woodbury
  • Regional Cancer Center at Singing River Hospital
  • Cancer Institute of Cape Girardeau, LLC
  • Truman Medical Center - Hospital Hill
  • Saint Luke's Cancer Institute at Saint Luke's Hospital
  • St. Joseph Medical Center
  • North Kansas City Hospital
  • Parvin Radiation Oncology
  • CCOP - Kansas City
  • Research Medical Center
  • Saint Luke's East - Lee's Summit
  • Liberty Hospital
  • Heartland Regional Medical Center
  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
  • Barnes-Jewish West County Hospital
  • Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
  • CCOP - Cancer Research for the Ozarks
  • Hulston Cancer Center at Cox Medical Center South
  • Nebraska Medical Center
  • University Medical Center of Southern Nevada
  • CCOP - Nevada Cancer Research Foundation
  • Renown Institute for Cancer at Renown Regional Medical Center
  • Kingsbury Center for Cancer Care at Cheshire Medical Center
  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
  • Monmouth Medical Center
  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
  • J. Phillip Citta Regional Cancer Center at Community Medical Center
  • Maimonides Cancer Center at Maimonides Medical Center
  • Monter Cancer Center of the North Shore-LIJ Health System
  • CCOP - North Shore University Hospital
  • Don Monti Comprehensive Cancer Center at North Shore University Hospital
  • Long Island Jewish Medical Center
  • Wayne Memorial Hospital, Incorporated
  • Wayne Radiation Oncology
  • Summa Center for Cancer Care at Akron City Hospital
  • Barberton Citizens Hospital
  • Charles M. Barrett Cancer Center at University Hospital
  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
  • Cancer Care Center, Incorporated
  • Precision Radiotherapy at University Pointe
  • Cancer Treatment Center
  • Oklahoma University Cancer Institute
  • Integris Oncology Services
  • Rosenfeld Cancer Center at Abington Memorial Hospital
  • Bryn Mawr Hospital
  • Northeast Radiation Oncology Center
  • Dale and Frances Hughes Cancer Center at Pocono Medical Center
  • Penn State Cancer Institute at Milton S. Hershey Medical Center
  • Riddle Memorial Hospital Cancer Center
  • Upper Delaware Valley Cancer Center
  • Cancer Center of Paoli Memorial Hospital
  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
  • Frankford Hospital Cancer Center - Torresdale Campus
  • CCOP - Main Line Health
  • Lankenau Cancer Center at Lankenau Hospital
  • Rhode Island Hospital Comprehensive Cancer Center
  • Hollings Cancer Center at Medical University of South Carolina
  • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
  • American Fork Hospital
  • Sandra L. Maxwell Cancer Center
  • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
  • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
  • Utah Valley Regional Medical Center - Provo
  • Dixie Regional Medical Center - East Campus
  • LDS Hospital
  • Utah Cancer Specialists at UCS Cancer Center
  • Norris Cotton Cancer Center - North
  • University of Virginia Cancer Center
  • Southwest Virginia Regional Cancer Center at Wellmonth Health
  • Columbia Saint Mary's Hospital - Ozaukee
  • Columbia-Saint Mary's Cancer Care Center
  • Medical College of Wisconsin Cancer Center
  • London Regional Cancer Program at London Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

IMRT + Chemotherapy , Resection, Postoperative Chemotherapy

Arm Description

Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)

Outcomes

Primary Outcome Measures

The Percentage of Patients Experiencing Treatment-related Gastrointestinal Adverse Events ≥ Grade 2 Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0, Occurring Preoperatively
The percentage of patients experiencing preoperative treatment-related gastrointestinal adverse events ≥ grade 2. If patient did not receive surgery, then such adverse events <= 90 days from the start of concurrent treatment are included.

Secondary Outcome Measures

Number of Patients in Protocol Adherence Categories for Intensity-modulated Radiotherapy (IMRT) Planning
Real-time quality assurance was performed remotely by the study chair or the radiation oncology co-chair prior to initiation of treatment for the first 40 cases. The final cases enrolled were reviewed within 3 months after accrual was completed. Review included evaluation of clinical target volume (CTV) and planning target volume (PTV), Organs at Risk (OARs), and treatment plan dosimetry.
Number of Patients With Pathologic Complete Response
Pathologic complete response is defined as no evidence of residual cancer histologically in the resection specimen.
Percentage of Patients With Grade 3 or Higher Treatment-related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 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. Adverse events were compiled in four different time periods: 1) Preoperative: Preoperatively or, if no surgery, then ≤ 90 days from the Start of Concurrent Treatment; 2) Postoperative#1: Postoperatively and ≤ 30 days from the Date of Surgery; 3) Postoperative#2: Postoperatively and ≤ 90 days from the End of Postoperative Chemotherapy; 4) Overall: From start of concurrent treatment to end of follow-up;
Local-regional Failure: 4-year Rate
Local failure is defined as: (1) any recurrence or surgery to the primary site after a complete response (CR) reported at surgery or reported after the end of protocol treatment; or (2) persistence [failure at one day post study entry], absence of CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment. Regional failure is defined as: (1) any recurrence after a nodal CR reported at surgery or reported after the end of protocol treatment; or (2) persistence, absence of nodal CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment. Local-regional failure time is defined as time from registration to local or regional failure, last known follow-up (censored), or death (competing risk). Local-regional failure rates are estimated by the cumulative incidence method.
Distant Failure: 4-year Rate
Distant failure is defined as the appearance of peritoneal seeding or distant metastases. Time to distant failure is defined as time from registration to the date of distant failure, last known follow-up (censored), or death (competing risk). Distant failure rates are estimated by the cumulative incidence method.
Overall Survival: 4-year Rate
Overall survival time is defined as time from registration to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
Disease-free Survival: 4-year Rate
Disease is defined as local-regional failure or distant failure. Distant failure is defined as the appearance of peritoneal seeding or distant metastases. Local-regional failure is defined as: (1) any recurrence or surgery to the primary site after a complete response (CR) / any recurrence after a nodal CR - reported at surgery or reported after the end of protocol treatment; or (2) persistence [failure at one day post study entry], absence of primary/nodal CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment. Disease-free survival time is defined as time from registration to the date of disease, death, or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method.
Number of Patients Who Underwent Abdominoperineal Resection
All patients were to undergo surgery 4 to 8 weeks following the completion of radiation therapy. The choice of procedure (abdominoperineal resection (APR), low anterior resection (LAR), or LAR/coloanal anastomosis) was at the discretion of the surgeon. If more than 28 patients received abdominoperineal resection, this would result in a conclusion of an excessive number of abdominoperineal resections.

Full Information

First Posted
February 9, 2008
Last Updated
August 27, 2018
Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI), NRG Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT00613080
Brief Title
Combination Chemotherapy and Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer
Official Title
A Phase II Evaluation of Preoperative Chemoradiotherapy Utilizing Intensity Modulated Radiation Therapy (IMRT) in Combination With Capecitabine and Oxaliplatin for Patients With Locally Advanced Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
December 2016 (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: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with intensity-modulated radiation therapy works in treating patients undergoing surgery for locally advanced rectal cancer.
Detailed Description
OBJECTIVES: Primary To determine whether the incidence of neoadjuvant acute gastrointestinal toxicity (grade ≥ 2) associated with neoadjuvant chemoradiotherapy is reduced by inverse-planned intensity-modulated radiotherapy (IMRT)-based radiation treatment when compared with conventionally delivered radiotherapy, as was utilized in the capecitabine and oxaliplatin arm of RTOG-0247 (NCT00081289). Secondary To evaluate the feasibility of performing IMRT in a cooperative group setting for the treatment of rectal cancer. To estimate the incidence of all toxicity (hematologic and non-hematologic) associated with protocol treatment in the neoadjuvant period, the adjuvant period, and overall. To estimate the pathologic complete response rate following neoadjuvant IMRT-based chemoradiotherapy. To estimate the time to treatment failure and patterns of failure. To correlate pre- and post-treatment levels of serum cytokines with symptoms during and pathological outcomes following neoadjuvant chemoradiotherapy for rectal cancer. To evaluate the rate of abdominoperineal resections. OUTLINE: This is a multicenter study. Chemoradiotherapy: Patients undergo inverse-planned intensity-modulated radiotherapy to the pelvis once daily, 5 days a week, for 5 weeks (total of 45 Gy) and a 3-dimensional conformal radiotherapy boost to gross disease once daily for 3 days (total of 45 Gy). Beginning on the first day of radiotherapy and continuing through completion of radiotherapy, patients receive oral capecitabine twice daily, 5 days a week, for 5 weeks and oxaliplatin IV over 2 hours on days 1, 8, 15, 22, 29. Surgery: Within 4-8 weeks after completion of chemoradiotherapy, patients undergo resection of the rectal tumor. Adjuvant chemotherapy: Beginning 4-8 weeks after surgery, patients with completely resected disease and negative surgical margins receive leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on day 1 and fluorouracil IV bolus on day 1 and fluorouracil IV infusion continuously over 46 hours beginning on day 1 . Treatment repeats every 14 days for up to 9 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months after the start of treatment for 2 years, every 6 months for years 3-5, and then annually thereafter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage III rectal cancer, adenocarcinoma of the rectum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMRT + Chemotherapy , Resection, Postoperative Chemotherapy
Arm Type
Other
Arm Description
Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Description
1650 mg/m^2/day orally 5 days/week during radiotherapy.
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Other Intervention Name(s)
50 mg/m^2 IV over 2 hours weekly for five weeks starting on day 1 of radiotherapy.
Intervention Type
Procedure
Intervention Name(s)
resection
Intervention Description
All patients undergo surgery 4 to 8 weeks following the completion of radiation therapy. The choice of procedure (abdominoperineal resection (APR), low anterior resection (LAR), or LAR/coloanal anastomosis) is at the discretion of the surgeon.
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Intervention Description
Pelvic intensity modulated radiation therapy (IMRT): 45 Gy in 25 fx Three dimensional conformal radiation therapy (3D-CRT) boost: 5.4 Gy in 3 fx to total dose of 50.4 Gy in 28 fx
Intervention Type
Drug
Intervention Name(s)
FOLFOX
Other Intervention Name(s)
Oxaliplatin, leucovorin, 5-fluorouracil
Intervention Description
Postoperative chemotherapy is administered to all patients who have a complete resection of rectal cancer with negative surgical margins and begins within 4-8 weeks following surgical resection, consisting of a total of 9 14-day cycles. Oxaliplatin 85 mg/m^2, IV over 2 hours, day 1. Leucovorin 400 mg/m^2, IV over 2 hours, day 1. 5-fluorouracil bolus 400 mg/m^2, IV push, day 1. 5-fluorouracil infusion 2400 mg/m^2, IV continuous infusion over 46 hours, day 1.
Primary Outcome Measure Information:
Title
The Percentage of Patients Experiencing Treatment-related Gastrointestinal Adverse Events ≥ Grade 2 Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0, Occurring Preoperatively
Description
The percentage of patients experiencing preoperative treatment-related gastrointestinal adverse events ≥ grade 2. If patient did not receive surgery, then such adverse events <= 90 days from the start of concurrent treatment are included.
Time Frame
From start of treatment to surgery or ≤ 90 days from the Start of Concurrent Treatment (for patients not undergoing surgery)
Secondary Outcome Measure Information:
Title
Number of Patients in Protocol Adherence Categories for Intensity-modulated Radiotherapy (IMRT) Planning
Description
Real-time quality assurance was performed remotely by the study chair or the radiation oncology co-chair prior to initiation of treatment for the first 40 cases. The final cases enrolled were reviewed within 3 months after accrual was completed. Review included evaluation of clinical target volume (CTV) and planning target volume (PTV), Organs at Risk (OARs), and treatment plan dosimetry.
Time Frame
Pretreatment
Title
Number of Patients With Pathologic Complete Response
Description
Pathologic complete response is defined as no evidence of residual cancer histologically in the resection specimen.
Time Frame
At the time of surgery, which is 4-8 weeks after radiation therapy, approximately 9-13 weeks from treatment start.
Title
Percentage of Patients With Grade 3 or Higher Treatment-related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Description
Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 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. Adverse events were compiled in four different time periods: 1) Preoperative: Preoperatively or, if no surgery, then ≤ 90 days from the Start of Concurrent Treatment; 2) Postoperative#1: Postoperatively and ≤ 30 days from the Date of Surgery; 3) Postoperative#2: Postoperatively and ≤ 90 days from the End of Postoperative Chemotherapy; 4) Overall: From start of concurrent treatment to end of follow-up;
Time Frame
From study registration to end of follow-up. Maximum follow-up at time of analysis was 5.2 years.
Title
Local-regional Failure: 4-year Rate
Description
Local failure is defined as: (1) any recurrence or surgery to the primary site after a complete response (CR) reported at surgery or reported after the end of protocol treatment; or (2) persistence [failure at one day post study entry], absence of CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment. Regional failure is defined as: (1) any recurrence after a nodal CR reported at surgery or reported after the end of protocol treatment; or (2) persistence, absence of nodal CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment. Local-regional failure time is defined as time from registration to local or regional failure, last known follow-up (censored), or death (competing risk). Local-regional failure rates are estimated by the cumulative incidence method.
Time Frame
From registration to four years
Title
Distant Failure: 4-year Rate
Description
Distant failure is defined as the appearance of peritoneal seeding or distant metastases. Time to distant failure is defined as time from registration to the date of distant failure, last known follow-up (censored), or death (competing risk). Distant failure rates are estimated by the cumulative incidence method.
Time Frame
From registration to four years
Title
Overall Survival: 4-year Rate
Description
Overall survival time is defined as time from registration to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
Time Frame
From registration to four years
Title
Disease-free Survival: 4-year Rate
Description
Disease is defined as local-regional failure or distant failure. Distant failure is defined as the appearance of peritoneal seeding or distant metastases. Local-regional failure is defined as: (1) any recurrence or surgery to the primary site after a complete response (CR) / any recurrence after a nodal CR - reported at surgery or reported after the end of protocol treatment; or (2) persistence [failure at one day post study entry], absence of primary/nodal CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment. Disease-free survival time is defined as time from registration to the date of disease, death, or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method.
Time Frame
From registration to four years
Title
Number of Patients Who Underwent Abdominoperineal Resection
Description
All patients were to undergo surgery 4 to 8 weeks following the completion of radiation therapy. The choice of procedure (abdominoperineal resection (APR), low anterior resection (LAR), or LAR/coloanal anastomosis) was at the discretion of the surgeon. If more than 28 patients received abdominoperineal resection, this would result in a conclusion of an excessive number of abdominoperineal resections.
Time Frame
Surgery occurred 4 to 8 weeks following the completion of radiation therapy, approximately 9-13 weeks from start of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Pathologically confirmed diagnosis of adenocarcinoma of the rectum by biopsy technique that does not completely excise the lesion (e.g., fine needle aspiration, core needle biopsy) Located up to 12 cm from the anal verge with no extension of malignant disease into the anal canal Clinically determined to be stage T3 or T4,N0-N2, and M0 tumor as determined by the following assessments: Colonoscopy and biopsy within 56 days prior to registration History/physical examination (including medication history screen for contraindications) within 56 days prior to registration Contrast-enhanced imaging of the abdomen and pelvis either by computed tomography(CT), MRI, or Positron-emission tomography(PET)-CT (whole body preferred) within 56 days prior to registration Chest x-ray (or CT) of the chest within within 56 days prior to registration to exclude distant metastases (except for patients who have had whole body PET-CT) Transrectal ultrasound (TRUS) within 56 days prior to registration required to establish tumor stage TRUS not required if clinical exam, CT of the pelvis, and/or MRI demonstrates T4 lesion No synchronous primary colon carcinoma No evidence of distant metastases (M1) PATIENT CHARACTERISTICS: Inclusion criteria: Zubrod performance status 0-2 Absolute neutrophil count (ANC) ≥ 1,800/mm³ Platelet count ≥ 100,000/mm³ Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve hemoglobin ≥ 8.0 g/dL allowed) Aspartate aminotransferase (AST) < 2.5 times upper limit of normal (ULN) Alkaline phosphatase < 2.5 times ULN Bilirubin ≤ 1.5 times ULN Creatinine clearance > 50 mL/min Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior invasive malignancy except nonmelanoma skin cancer unless disease free for a minimum of 3 years Exclusion criteria: Severe, active comorbidity, defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within the past 12 months Transmural myocardial infarction within the past 6 months Acute bacterial or fungal infection requiring intravenous antibiotics Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within the past 30 days Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects AIDS Evidence of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake Known, existing uncontrolled coagulopathy, unless clinically stable on anticoagulation therapy for ≥ 2 weeks Evidence of peripheral neuropathy ≥ grade 2 Prior allergic reaction to oxaliplatin or capecitabine Lack of physical integrity of the gastrointestinal tract (i.e., severe Crohn disease that results in malabsorption; significant bowel resection that would make one concerned about the absorption of capecitabine) or malabsorption syndrome that would preclude feasibility of oral chemotherapy (i.e., capecitabine) Prior systemic chemotherapy for colorectal cancer (prior chemotherapy allowed provided it was for a cancer other than colorectal cancer) Prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields Major surgery within 28 days of study enrollment(other than diverting colostomy without tumor resection) Participation in any investigational drug study within 28 days of study enrollment. Concurrent cimetidine, amifostine, and/or depot Sandostatin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael C. Garofalo, MD
Organizational Affiliation
University of Maryland Greenebaum Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adam C. Berger, MD
Organizational Affiliation
Sidney Kimmel Cancer Center at Thomas Jefferson University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Johanna Bendell, MD
Organizational Affiliation
Duke Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Providence Cancer Center at Providence Hospital
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Auburn Radiation Oncology
City
Auburn
State/Province
California
ZIP/Postal Code
95603
Country
United States
Facility Name
Radiation Oncology Centers - Cameron Park
City
Cameron Park
State/Province
California
ZIP/Postal Code
95682
Country
United States
Facility Name
Mercy Cancer Center at Mercy San Juan Medical Center
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
California Cancer Center - Woodward Park Office
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Rebecca and John Moores UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0658
Country
United States
Facility Name
Radiation Oncology Center - Roseville
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Radiological Associates of Sacramento Medical Group, Incorporated
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
Mercy General Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Veterans Affairs Medical Center - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Solano Radiation Oncology Center
City
Vacaville
State/Province
California
ZIP/Postal Code
95687
Country
United States
Facility Name
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
University of Florida Shands Cancer Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0232
Country
United States
Facility Name
Baptist Cancer Institute - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Baptist-South Miami Regional Cancer Program
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Integrated Community Oncology Network - Orange Park
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Bay Medical
City
Panama City
State/Province
Florida
ZIP/Postal Code
32401
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
John B. Amos Cancer Center
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31403-3089
Country
United States
Facility Name
Cancer Institute at St. John's Hospital
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Saint John's Cancer Center at Saint John's Medical Center
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46016
Country
United States
Facility Name
Center for Cancer Care at Goshen General Hospital
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
St. Vincent Oncology Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Cancer Center at Ball Memorial Hospital
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303-3499
Country
United States
Facility Name
Menorah Medical Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
Saint Luke's Hospital - South
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66213
Country
United States
Facility Name
Shawnee Mission Medical Center
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Greenebaum Cancer Center at University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber/Brigham and Women's Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston University Cancer Research Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Hudner Oncology Center at Saint Anne's Hospital - Fall River
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02721
Country
United States
Facility Name
Fairview Ridges Hospital
City
Burnsville
State/Province
Minnesota
ZIP/Postal Code
55337
Country
United States
Facility Name
Mercy and Unity Cancer Center at Mercy Hospital
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Fairview Southdale Hospital
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Mercy and Unity Cancer Center at Unity Hospital
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Minnesota Oncology Hematology, PA - Maplewood
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422-2900
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Park Nicollet Cancer Center
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
United Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
St. Francis Cancer Center at St. Francis Medical Center
City
Shakopee
State/Province
Minnesota
ZIP/Postal Code
55379
Country
United States
Facility Name
Ridgeview Medical Center
City
Waconia
State/Province
Minnesota
ZIP/Postal Code
55387
Country
United States
Facility Name
Minnesota Oncology Hematology, PA - Woodbury
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
Regional Cancer Center at Singing River Hospital
City
Pascagoula
State/Province
Mississippi
ZIP/Postal Code
39581
Country
United States
Facility Name
Cancer Institute of Cape Girardeau, LLC
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63703
Country
United States
Facility Name
Truman Medical Center - Hospital Hill
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Saint Luke's Cancer Institute at Saint Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
St. Joseph Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
North Kansas City Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64116
Country
United States
Facility Name
Parvin Radiation Oncology
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64116
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Saint Luke's East - Lee's Summit
City
Lee's Summit
State/Province
Missouri
ZIP/Postal Code
64086
Country
United States
Facility Name
Liberty Hospital
City
Liberty
State/Province
Missouri
ZIP/Postal Code
64068
Country
United States
Facility Name
Heartland Regional Medical Center
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Barnes-Jewish West County Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Facility Name
CCOP - Cancer Research for the Ozarks
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65802
Country
United States
Facility Name
Hulston Cancer Center at Cox Medical Center South
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
University Medical Center of Southern Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
CCOP - Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Renown Institute for Cancer at Renown Regional Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Kingsbury Center for Cancer Care at Cheshire Medical Center
City
Keene
State/Province
New Hampshire
ZIP/Postal Code
03431
Country
United States
Facility Name
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
Monmouth Medical Center
City
Long Branch
State/Province
New Jersey
ZIP/Postal Code
07740-6395
Country
United States
Facility Name
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
J. Phillip Citta Regional Cancer Center at Community Medical Center
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Maimonides Cancer Center at Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Facility Name
Monter Cancer Center of the North Shore-LIJ Health System
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
CCOP - North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Don Monti Comprehensive Cancer Center at North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
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
Wayne Memorial Hospital, Incorporated
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Wayne Radiation Oncology
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Summa Center for Cancer Care at Akron City Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44309-2090
Country
United States
Facility Name
Barberton Citizens Hospital
City
Barberton
State/Province
Ohio
ZIP/Postal Code
44203
Country
United States
Facility Name
Charles M. Barrett Cancer Center at University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
Cancer Care Center, Incorporated
City
Salem
State/Province
Ohio
ZIP/Postal Code
44460
Country
United States
Facility Name
Precision Radiotherapy at University Pointe
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Facility Name
Cancer Treatment Center
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
Oklahoma University Cancer Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Integris Oncology Services
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Rosenfeld Cancer Center at Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Bryn Mawr Hospital
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Northeast Radiation Oncology Center
City
Dunmore
State/Province
Pennsylvania
ZIP/Postal Code
18512
Country
United States
Facility Name
Dale and Frances Hughes Cancer Center at Pocono Medical Center
City
East Stroudsburg
State/Province
Pennsylvania
ZIP/Postal Code
18301
Country
United States
Facility Name
Penn State Cancer Institute at Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Riddle Memorial Hospital Cancer Center
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Upper Delaware Valley Cancer Center
City
Milford
State/Province
Pennsylvania
ZIP/Postal Code
18337
Country
United States
Facility Name
Cancer Center of Paoli Memorial Hospital
City
Paoli
State/Province
Pennsylvania
ZIP/Postal Code
19301-1792
Country
United States
Facility Name
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-5541
Country
United States
Facility Name
Frankford Hospital Cancer Center - Torresdale Campus
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
CCOP - Main Line Health
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Lankenau Cancer Center at Lankenau Hospital
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Rhode Island Hospital Comprehensive Cancer Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Hollings Cancer Center at Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37662
Country
United States
Facility Name
American Fork Hospital
City
American Fork
State/Province
Utah
ZIP/Postal Code
84003
Country
United States
Facility Name
Sandra L. Maxwell Cancer Center
City
Cedar City
State/Province
Utah
ZIP/Postal Code
84720
Country
United States
Facility Name
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84157
Country
United States
Facility Name
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Utah Valley Regional Medical Center - Provo
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
Dixie Regional Medical Center - East Campus
City
Saint George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84103
Country
United States
Facility Name
Utah Cancer Specialists at UCS Cancer Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Norris Cotton Cancer Center - North
City
Saint Johnsbury
State/Province
Vermont
ZIP/Postal Code
05819
Country
United States
Facility Name
University of Virginia Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Southwest Virginia Regional Cancer Center at Wellmonth Health
City
Norton
State/Province
Virginia
ZIP/Postal Code
24273
Country
United States
Facility Name
Columbia Saint Mary's Hospital - Ozaukee
City
Mequon
State/Province
Wisconsin
ZIP/Postal Code
53097
Country
United States
Facility Name
Columbia-Saint Mary's Cancer Care Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States
Facility Name
Medical College of Wisconsin Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
London Regional Cancer Program at London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Combination Chemotherapy and Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer

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