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Bevacizumab, Radiation Therapy, and Cisplatin in Treating Patients With Previously Untreated Locally Advanced Cervical Cancer

Primary Purpose

Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Bevacizumab
Cisplatin
External Beam Radiation Therapy
Internal Radiation Therapy
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Adenocarcinoma

Eligibility Criteria

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

Inclusion Criteria: Histologically confirmed squamous cell, adenocarcinoma, or adenosquamous cell carcinoma of the uterine cervix, meeting 1 of the following stage criteria: Stage IIB-IIIB lymph nodes Stage IB-IIA disease with biopsy-proven pelvic node metastases and/or tumor size >= 5 cm No positive para-aortic lymph nodes Zubrod performance status 0-2 WBC >= 3,000/mm^3 Absolute granulocyte count >= 1,500/mm^3 Platelet count >= 100,000/mm^3 INR < 1.5 Total bilirubin =< 1.5 mg/dL Serum creatinine =< 1.5 mg/dL AST and ALT =< 2.5 times upper limit of normal (ULN) Serum calcium =< 1.3 times ULN Hemoglobin >= 10 g/dL (transfusion allowed) Urine protein:creatinine ratio ? 0.5 OR urine protein < 1,000 mg by 24-hour urine collection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception None of the following illnesses or conditions: Medical illness preventing the use of full-dose chemotherapy Evidence of bleeding diathesis or coagulopathy Prior medical or psychiatric illness that would prevent informed consent or limit survival to < 6 months History of aneurysms, cerebrovascular accident, or arteriovenous malformations Active gastrointestinal (GI) ulcers, GI bleeding, or active inflammatory bowel disease Serious, nonhealing wound, ulcer, or current healing fracture History of any type of fistula or GI perforation Intra-abdominal abscess within the past 6 months No prior invasive malignancy (except nonmelanomatous skin cancer) unless disease free for >= 3 years No significant traumatic injury within the past 28 days No clinically significant cardiovascular disease, such as the following: Uncontrolled hypertension (blood pressure > 160/90 mm Hg on medication) Myocardial infarction within the past 12 months Unstable angina within the past 12 months New York Heart Association class II-IV congestive heart failure Unstable symptomatic arrhythmia requiring medication (i.e., chronic atrial arrhythmia, atrial fibrillation, or paroxysmal supraventricular tachycardia) Arterial thromboembolic events, including transient ischemic attack or clinically significant peripheral artery disease, within the past 6 months Arterial thromboembolic events, including transient ischemic attack or clinically significant peripheral artery disease, within the past 6 months No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies No known HIV No prior organ transplant No prior surgery for carcinoma of the cervix other than biopsy No prior surgical debulking of pelvic or para-aortic nodes No prior pelvic radiotherapy, including transvaginal irradiation to control bleeding No prior systemic chemotherapy No major surgical procedure or open biopsy within the past 28 days or anticipation of need for major surgical procedure during the course of the study No fine needle aspirations or core biopsies within the past 7 days No concurrent major surgical procedure No concurrent epoetin alfa or Hypericum perforatum (St. John's wort) No concurrent intensity-modulated radiotherapy No concurrent transvaginal irradiation to control bleeding

Sites / Locations

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
  • University of California Davis Comprehensive Cancer Center
  • Penrose-Saint Francis Healthcare
  • University of Colorado
  • Integrated Community Oncology Network-Florida Cancer Center Beaches
  • Baptist MD Anderson Cancer Center
  • Integrated Community Oncology Network-Southside Cancer Center
  • University of Florida Health Science Center - Jacksonville
  • Baptist Medical Center South
  • 21st Century Oncology-Orange Park
  • UF Cancer Center at Orlando Health
  • 21st Century Oncology-Palatka
  • Bay Medical Center
  • Integrated Community Oncology Network-Flager Cancer Center
  • Grady Health System
  • Emory University Hospital/Winship Cancer Institute
  • Northwest Community Hospital
  • Northwestern University
  • John H Stroger Jr Hospital of Cook County
  • Franciscan St. James Health-Olympia Fields Campus
  • Methodist Medical Center of Illinois
  • Saint Vincent Anderson Regional Hospital/Cancer Center
  • Franciscan Saint Francis Health-Beech Grove
  • Saint Vincent Hospital and Health Care Center
  • Reid Health
  • Providence Medical Center
  • Lawrence Memorial Hospital
  • Menorah Medical Center
  • Radiation Oncology Practice Corporation Southwest
  • Saint Luke's South Hospital
  • Shawnee Mission Medical Center-KCCC
  • Baptist Health Lexington
  • Norton Suburban Hospital and Medical Campus
  • Brigham and Women's Hospital
  • Boston Medical Center
  • University of Michigan Comprehensive Cancer Center
  • Borgess Medical Center
  • Bronson Methodist Hospital
  • West Michigan Cancer Center
  • Cape Radiation Oncology
  • Centerpoint Medical Center LLC
  • Truman Medical Center
  • Saint Luke's Hospital of Kansas City
  • Radiation Oncology Practice Corporation South
  • Saint Joseph Health Center
  • North Kansas City Hospital
  • Research Medical Center
  • Radiation Oncology Practice Corporation - North
  • Saint Luke's East - Lee's Summit
  • Liberty Radiation Oncology Center
  • Heartland Regional Medical Center
  • CHI Health Good Samaritan
  • University Medical Center of Southern Nevada
  • Saint Barnabas Medical Center
  • Monmouth Medical Center
  • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
  • Rutgers Cancer Institute of New Jersey
  • Newark Beth Israel Medical Center
  • New York-Presbyterian/Brooklyn Methodist Hospital
  • Roswell Park Cancer Institute
  • Highland Hospital
  • University of Rochester
  • Wake Forest University Health Sciences
  • Summa Akron City Hospital/Cooper Cancer Center
  • Summa Barberton Hospital
  • Grandview Hospital
  • Good Samaritan Hospital - Dayton
  • Miami Valley Hospital
  • Samaritan North Health Center
  • Veteran Affairs Medical Center
  • Blanchard Valley Hospital
  • Atrium Medical Center-Middletown Regional Hospital
  • Kettering Medical Center
  • Cancer Care Center, Incorporated
  • Upper Valley Medical Center
  • Clinton Memorial Hospital
  • Cancer Treatment Center
  • Wright-Patterson Medical Center
  • Greene Memorial Hospital
  • Bryn Mawr Hospital
  • Paoli Memorial Hospital
  • Einstein Medical Center Philadelphia
  • Reading Hospital
  • Lankenau Medical Center
  • Main Line Health NCORP
  • Wellmont Holston Valley Hospital and Medical Center
  • M D Anderson Cancer Center
  • American Fork Hospital / Huntsman Intermountain Cancer Center
  • Sandra L Maxwell Cancer Center
  • Logan Regional Hospital
  • Cottonwood Hospital Medical Center
  • Intermountain Medical Center
  • McKay-Dee Hospital Center
  • Utah Valley Regional Medical Center
  • Dixie Medical Center Regional Cancer Center
  • Intermountain Health Care
  • Utah Cancer Specialists-Salt Lake City
  • Huntsman Cancer Institute/University of Utah
  • LDS Hospital
  • Southwest VA Regional Cancer Center
  • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
  • Gundersen Lutheran Medical Center
  • Froedtert and the Medical College of Wisconsin
  • London Regional Cancer Program
  • McGill University Department of Oncology
  • Allan Blair Cancer Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (radiation therapy, bevacizumab, cisplatin)

Arm Description

Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy. Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35.

Outcomes

Primary Outcome Measures

Number of Subjects With Treatment-related Serious Adverse Events (SAEs) and Adverse Events (AEs) as Assessed by CTCAE v. 3.0 Criteria Within the First 90 Days From Treatment Start.
Adverse events (AEs) graded using CTCAE v3.0. Grade (Gr) refers to the severity of the AE and assigns Gr 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: 1= Mild AE, 2= Moderate AE, 3= Severe AE, 4= Life-threatening or disabling AE, 5= Death related to AE. Treatment-related SAEs defined as Grade (Gr) >= 4 vaginal bleeding, Gr >=4 thrombotic event, Gr >=3 arterial event, gastrointestinal (GI) bleeding , or bowel/bladder perforation, and any Gr 5 treatment-related AE. Treatment-related AEs defined as all SAEs, Gr 3-4 nausea, vomiting, or diarrhea persisting for >2 weeks despite medical intervention, Gr 4 neutropenia or leukopenia persisting for >7 days, febrile neutropenia defined as a temperature >38.5 degree Celsius and granulocytes < 1000/mm3, Grade 3-4 hematologic toxicity with the exception of neutropenia and leukopenia, and Grade 3-4 GI, renal, cardiac, pulmonary, hepatic, or neurologic AEs.

Secondary Outcome Measures

Number of Subjects With Treatment-related SAEs and AEs as Assessed by CTCAE v. 3.0 Criteria at Any Time.
Adverse events (AEs) graded using CTCAE v3.0. Grade (Gr) refers to the severity of the AE and assigns Gr 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: 1= Mild AE, 2= Moderate AE, 3= Severe AE, 4= Life-threatening or disabling AE, 5= Death related to AE. Treatment-related SAEs defined as Gr >= 4 vaginal bleeding, Gr >=4 thrombotic event, Gr >=3 arterial event, gastrointestinal (GI) bleeding , or bowel/bladder perforation, and any Gr 5 treatment-related AE. Treatment-related AEs defined as all SAEs, Gr 3-4 nausea, vomiting, or diarrhea persisting for >2 weeks despite medical intervention, Gr 4 neutropenia or leukopenia persisting for >7 days, febrile neutropenia defined as a temperature >38.5 degree Celsius and granulocytes < 1000/mm3, Grade 3-4 hematologic toxicity with the exception of neutropenia and leukopenia, and Grade 3-4 GI, renal, cardiac, pulmonary, hepatic, or neurologic AEs.
Disease-free Survival (Three-year Rate Reported)
Failure is defined as local, regional, or distant disease, or death due to any cause. Disease-free survival time is defined as time from registration to the date of failure and disease-free survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive and disease-free are censored at the date of last contact.
Overall Survival (Three-year Rate Reported)
Overall survival time is defined as time from registration to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.

Full Information

First Posted
August 24, 2006
Last Updated
February 21, 2018
Sponsor
National Cancer Institute (NCI)
Collaborators
Radiation Therapy Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT00369122
Brief Title
Bevacizumab, Radiation Therapy, and Cisplatin in Treating Patients With Previously Untreated Locally Advanced Cervical Cancer
Official Title
A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 11, 2006 (Actual)
Primary Completion Date
June 4, 2010 (Actual)
Study Completion Date
December 15, 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
This phase II trial is studying how well giving bevacizumab together with radiation therapy and cisplatin works in treating patients with previously untreated locally advanced cervical cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of cervical cancer by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with radiation therapy and cisplatin may kill more tumor cells.
Detailed Description
PRIMARY OBJECTIVES: I. Determine treatment-related serious adverse-event rates and adverse-event rates within the first 90 days from treatment start in patients with previously untreated locally advanced carcinoma of the cervix treated with bevacizumab, cisplatin, and concurrent pelvic radiotherapy. SECONDARY OBJECTIVES: I. Evaluate treatment-related serious adverse events and adverse events at any time. II. Evaluate disease-free survival (local, regional, or distant failure, or death due to any cause). III. Evaluate overall survival (death due to any cause). IV. Implement the image-based brachytherapy guidelines proposed by the Transatlantic Image-Guided Brachytherapy Working Group. V. Collect CT scan or MRI-based dosimetry of brachytherapy applications used during the course of treatment for later analysis of feasibility and consistency as well as dose/volume assessments of tumor control and complications. OUTLINE: This is a multicenter study. Patients undergo pelvic external-beam radiotherapy (EBRT) once daily, 5 days a week, for 5 weeks for a total of 45 Gy. Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35. After completion of study treatment, patients are followed periodically.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Stage IB Cervical Cancer AJCC v6 and v7, Stage IIA Cervical Cancer AJCC v7, Stage IIB Cervical Cancer AJCC v6 and v7, Stage III Cervical Cancer AJCC v6 and v7

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Treatment (radiation therapy, bevacizumab, cisplatin)
Arm Type
Experimental
Arm Description
Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy. Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35.
Intervention Type
Biological
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar FKB238, BEVACIZUMAB, LICENSE HOLDER UNSPECIFIED, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin
Intervention Description
Given IV
Intervention Type
Radiation
Intervention Name(s)
External Beam Radiation Therapy
Other Intervention Name(s)
Definitive Radiation Therapy, EBRT, External Beam Radiotherapy, External Beam RT, external radiation, External Radiation Therapy, external-beam radiation
Intervention Description
Undergo EBRT
Intervention Type
Radiation
Intervention Name(s)
Internal Radiation Therapy
Other Intervention Name(s)
BRACHYTHERAPY, internal radiation, Internal Radiation Brachytherapy, Radiation Brachytherapy
Intervention Description
Undergo brachytherapy
Primary Outcome Measure Information:
Title
Number of Subjects With Treatment-related Serious Adverse Events (SAEs) and Adverse Events (AEs) as Assessed by CTCAE v. 3.0 Criteria Within the First 90 Days From Treatment Start.
Description
Adverse events (AEs) graded using CTCAE v3.0. Grade (Gr) refers to the severity of the AE and assigns Gr 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: 1= Mild AE, 2= Moderate AE, 3= Severe AE, 4= Life-threatening or disabling AE, 5= Death related to AE. Treatment-related SAEs defined as Grade (Gr) >= 4 vaginal bleeding, Gr >=4 thrombotic event, Gr >=3 arterial event, gastrointestinal (GI) bleeding , or bowel/bladder perforation, and any Gr 5 treatment-related AE. Treatment-related AEs defined as all SAEs, Gr 3-4 nausea, vomiting, or diarrhea persisting for >2 weeks despite medical intervention, Gr 4 neutropenia or leukopenia persisting for >7 days, febrile neutropenia defined as a temperature >38.5 degree Celsius and granulocytes < 1000/mm3, Grade 3-4 hematologic toxicity with the exception of neutropenia and leukopenia, and Grade 3-4 GI, renal, cardiac, pulmonary, hepatic, or neurologic AEs.
Time Frame
From start of treatment to 90 days.
Secondary Outcome Measure Information:
Title
Number of Subjects With Treatment-related SAEs and AEs as Assessed by CTCAE v. 3.0 Criteria at Any Time.
Description
Adverse events (AEs) graded using CTCAE v3.0. Grade (Gr) refers to the severity of the AE and assigns Gr 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: 1= Mild AE, 2= Moderate AE, 3= Severe AE, 4= Life-threatening or disabling AE, 5= Death related to AE. Treatment-related SAEs defined as Gr >= 4 vaginal bleeding, Gr >=4 thrombotic event, Gr >=3 arterial event, gastrointestinal (GI) bleeding , or bowel/bladder perforation, and any Gr 5 treatment-related AE. Treatment-related AEs defined as all SAEs, Gr 3-4 nausea, vomiting, or diarrhea persisting for >2 weeks despite medical intervention, Gr 4 neutropenia or leukopenia persisting for >7 days, febrile neutropenia defined as a temperature >38.5 degree Celsius and granulocytes < 1000/mm3, Grade 3-4 hematologic toxicity with the exception of neutropenia and leukopenia, and Grade 3-4 GI, renal, cardiac, pulmonary, hepatic, or neurologic AEs.
Time Frame
From start of treatment to last follow-up, up to 6.0 years. Analysis occurred after all patients had been on study for at least 2 years.
Title
Disease-free Survival (Three-year Rate Reported)
Description
Failure is defined as local, regional, or distant disease, or death due to any cause. Disease-free survival time is defined as time from registration to the date of failure and disease-free survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive and disease-free are censored at the date of last contact.
Time Frame
From registration to 3 years
Title
Overall Survival (Three-year Rate Reported)
Description
Overall survival time is defined as time from registration to the date of death from any cause and is 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 3 years

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed squamous cell, adenocarcinoma, or adenosquamous cell carcinoma of the uterine cervix, meeting 1 of the following stage criteria: Stage IIB-IIIB lymph nodes Stage IB-IIA disease with biopsy-proven pelvic node metastases and/or tumor size >= 5 cm No positive para-aortic lymph nodes Zubrod performance status 0-2 WBC >= 3,000/mm^3 Absolute granulocyte count >= 1,500/mm^3 Platelet count >= 100,000/mm^3 INR < 1.5 Total bilirubin =< 1.5 mg/dL Serum creatinine =< 1.5 mg/dL AST and ALT =< 2.5 times upper limit of normal (ULN) Serum calcium =< 1.3 times ULN Hemoglobin >= 10 g/dL (transfusion allowed) Urine protein:creatinine ratio ? 0.5 OR urine protein < 1,000 mg by 24-hour urine collection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception None of the following illnesses or conditions: Medical illness preventing the use of full-dose chemotherapy Evidence of bleeding diathesis or coagulopathy Prior medical or psychiatric illness that would prevent informed consent or limit survival to < 6 months History of aneurysms, cerebrovascular accident, or arteriovenous malformations Active gastrointestinal (GI) ulcers, GI bleeding, or active inflammatory bowel disease Serious, nonhealing wound, ulcer, or current healing fracture History of any type of fistula or GI perforation Intra-abdominal abscess within the past 6 months No prior invasive malignancy (except nonmelanomatous skin cancer) unless disease free for >= 3 years No significant traumatic injury within the past 28 days No clinically significant cardiovascular disease, such as the following: Uncontrolled hypertension (blood pressure > 160/90 mm Hg on medication) Myocardial infarction within the past 12 months Unstable angina within the past 12 months New York Heart Association class II-IV congestive heart failure Unstable symptomatic arrhythmia requiring medication (i.e., chronic atrial arrhythmia, atrial fibrillation, or paroxysmal supraventricular tachycardia) Arterial thromboembolic events, including transient ischemic attack or clinically significant peripheral artery disease, within the past 6 months Arterial thromboembolic events, including transient ischemic attack or clinically significant peripheral artery disease, within the past 6 months No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies No known HIV No prior organ transplant No prior surgery for carcinoma of the cervix other than biopsy No prior surgical debulking of pelvic or para-aortic nodes No prior pelvic radiotherapy, including transvaginal irradiation to control bleeding No prior systemic chemotherapy No major surgical procedure or open biopsy within the past 28 days or anticipation of need for major surgical procedure during the course of the study No fine needle aspirations or core biopsies within the past 7 days No concurrent major surgical procedure No concurrent epoetin alfa or Hypericum perforatum (St. John's wort) No concurrent intensity-modulated radiotherapy No concurrent transvaginal irradiation to control bleeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracey Schefter
Organizational Affiliation
Radiation Therapy Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence Saint Joseph Medical Center/Disney Family Cancer Center
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
University of California Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Penrose-Saint Francis Healthcare
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80217-3364
Country
United States
Facility Name
Integrated Community Oncology Network-Florida Cancer Center Beaches
City
Jacksonville Beach
State/Province
Florida
ZIP/Postal Code
32250
Country
United States
Facility Name
Baptist MD Anderson Cancer Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Integrated Community Oncology Network-Southside Cancer Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
University of Florida Health Science Center - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Baptist Medical Center South
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32258
Country
United States
Facility Name
21st Century Oncology-Orange Park
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
UF Cancer Center at Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
21st Century Oncology-Palatka
City
Palatka
State/Province
Florida
ZIP/Postal Code
32177
Country
United States
Facility Name
Bay Medical Center
City
Panama City
State/Province
Florida
ZIP/Postal Code
32401
Country
United States
Facility Name
Integrated Community Oncology Network-Flager Cancer Center
City
Saint Augustine
State/Province
Florida
ZIP/Postal Code
32086
Country
United States
Facility Name
Grady Health System
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Emory University Hospital/Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwest Community Hospital
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
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
Country
United States
Facility Name
Franciscan St. James Health-Olympia Fields Campus
City
Olympia Fields
State/Province
Illinois
ZIP/Postal Code
60461
Country
United States
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
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 Francis Health-Beech Grove
City
Beech Grove
State/Province
Indiana
ZIP/Postal Code
46107
Country
United States
Facility Name
Saint Vincent Hospital and Health Care Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Reid Health
City
Richmond
State/Province
Indiana
ZIP/Postal Code
47374
Country
United States
Facility Name
Providence Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66112
Country
United States
Facility Name
Lawrence Memorial Hospital
City
Lawrence
State/Province
Kansas
ZIP/Postal Code
66044
Country
United States
Facility Name
Menorah Medical Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
Radiation Oncology Practice Corporation Southwest
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Saint Luke's South Hospital
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66213
Country
United States
Facility Name
Shawnee Mission Medical Center-KCCC
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Baptist Health Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Norton Suburban Hospital and Medical Campus
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Brigham and Women's Hospital
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
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Borgess Medical Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49001
Country
United States
Facility Name
Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Cape Radiation Oncology
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63703
Country
United States
Facility Name
Centerpoint Medical Center LLC
City
Independence
State/Province
Missouri
ZIP/Postal Code
64057
Country
United States
Facility Name
Truman Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Saint Luke's Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Radiation Oncology Practice Corporation South
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Saint Joseph Health 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
Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Radiation Oncology Practice Corporation - North
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64154
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 Radiation Oncology Center
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
CHI Health Good Samaritan
City
Kearney
State/Province
Nebraska
ZIP/Postal Code
68847
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
Saint Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
Monmouth Medical Center
City
Long Branch
State/Province
New Jersey
ZIP/Postal Code
07740
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
New York-Presbyterian/Brooklyn Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Highland Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
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
Grandview Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45405
Country
United States
Facility Name
Good Samaritan Hospital - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Samaritan North Health Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Veteran Affairs Medical Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45428
Country
United States
Facility Name
Blanchard Valley Hospital
City
Findlay
State/Province
Ohio
ZIP/Postal Code
45840
Country
United States
Facility Name
Atrium Medical Center-Middletown Regional Hospital
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005-1066
Country
United States
Facility Name
Kettering Medical Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Cancer Care Center, Incorporated
City
Salem
State/Province
Ohio
ZIP/Postal Code
44460
Country
United States
Facility Name
Upper Valley Medical Center
City
Troy
State/Province
Ohio
ZIP/Postal Code
45373
Country
United States
Facility Name
Clinton Memorial Hospital
City
Wilmington
State/Province
Ohio
ZIP/Postal Code
45177
Country
United States
Facility Name
Cancer Treatment Center
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
Wright-Patterson Medical Center
City
Wright-Patterson Air Force Base
State/Province
Ohio
ZIP/Postal Code
45433-5529
Country
United States
Facility Name
Greene Memorial Hospital
City
Xenia
State/Province
Ohio
ZIP/Postal Code
45385
Country
United States
Facility Name
Bryn Mawr Hospital
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Paoli Memorial Hospital
City
Paoli
State/Province
Pennsylvania
ZIP/Postal Code
19301
Country
United States
Facility Name
Einstein Medical Center Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Reading Hospital
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Lankenau Medical Center
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Main Line Health NCORP
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Wellmont Holston Valley Hospital and Medical Center
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
American Fork Hospital / Huntsman Intermountain Cancer Center
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
Logan Regional Hospital
City
Logan
State/Province
Utah
ZIP/Postal Code
84321
Country
United States
Facility Name
Cottonwood Hospital Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
McKay-Dee Hospital Center
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Utah Valley Regional Medical Center
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
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
Intermountain Health Care
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84103
Country
United States
Facility Name
Utah Cancer Specialists-Salt Lake City
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
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
Southwest VA Regional Cancer Center
City
Norton
State/Province
Virginia
ZIP/Postal Code
24273
Country
United States
Facility Name
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Facility Name
Gundersen Lutheran Medical Center
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
Froedtert and the Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
London Regional Cancer Program
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
McGill University Department of Oncology
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
Allan Blair Cancer Centre
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Bevacizumab, Radiation Therapy, and Cisplatin in Treating Patients With Previously Untreated Locally Advanced Cervical Cancer

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