Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Stage I Cancer of the Cervix
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of radiation therapy combined with chemotherapy, with or without surgery, is more effective in treating early cancer of the cervix.
PURPOSE: Randomized phase III trial to compare the effectiveness of surgery followed by different regimens of radiation therapy and chemotherapy with that of chemotherapy and radiation therapy alone in treating patients who have stage I cancer of the cervix.
Procedure: adjuvant therapy
Procedure: conventional surgery
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Treatment of Patients With Stage IB2 Carcinoma of the Cervix: A Randomized Comparison of Radical Hysterectomy and Tailored Chemo-Radiation Versus Primary Chemo-Radiation|
|Study Start Date:||February 2003|
|Primary Completion Date:||April 2005 (Final data collection date for primary outcome measure)|
- Compare progression-free survival and survival of patients with stage IB2 carcinoma of the cervix after radical hysterectomy with tailored chemoradiotherapy vs primary chemoradiotherapy.
- Compare the toxicity of these regimens in these patients.
- Compare the health-related quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Arm I: (Surgery followed by chemoradiotherapy): Patients undergo exploratory laparotomy followed by radical hysterectomy and bilateral pelvic and para-aortic lymphadenectomy. Depending on the findings at surgery, the radical hysterectomy and lymphadenectomy are either completed or aborted.
Aborted hysterectomy: Patients with aborted hysterectomy are assigned to 1 of 3 groups, depending on the findings at surgery.
- Group 1: Within 4 weeks of surgery, patients undergo pelvic radiotherapy 5 times weekly for 4-6 weeks and intracavitary irradiation during or after external radiotherapy. Patients also receive concurrent cisplatin IV over 1 hour once weekly for a total of 5-6 doses.
- Group 2: Patients receive radiotherapy and cisplatin as in group 1 with additional extended field radiotherapy.
- Group 3: Patients receive further treatment at the discretion of the investigator.
Completed hysterectomy: Patients completing the radical hysterectomy are assigned to 1 of 3 groups, depending on the findings at surgery.
- Group A: Patients receive treatment as in group 1 above without intracavity irradiation.
- Group B: Patients receive treatment as in group 2 above without intracavity irradiation.
- Group C: Patients receive no further treatment.
- Arm II (Primary chemoradiotherapy): Patients undergo pelvic radiotherapy 5 times weekly for 4-6 weeks and intracavity irradiation during or after external radiotherapy. Patients also receive concurrent cisplatin IV over 1 hour once weekly for a total of 6 doses.
Quality of life is assessed at baseline, during week 5 of therapy, and then at 3, 6, and 12 months.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 740 patients (370 per treatment arm) will be accrued for this study within 7.5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00054067
Hide Study Locations
|United States, Alabama|
|University of Alabama at Birmingham Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294-3300|
|United States, Arizona|
|CCOP - Western Regional, Arizona|
|Phoenix, Arizona, United States, 85006-2726|
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1740|
|Women's Cancer Center at Community Hospital of Los Gatos|
|Los Gatos, California, United States, 95032|
|Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center|
|Orange, California, United States, 92868|
|United States, Connecticut|
|Yale Comprehensive Cancer Center|
|New Haven, Connecticut, United States, 06520-8028|
|United States, Delaware|
|CCOP - Christiana Care Health Services|
|Newark, Delaware, United States, 19713|
|United States, District of Columbia|
|Walter Reed Army Medical Center|
|Washington, District of Columbia, United States, 20307-5001|
|United States, Illinois|
|MBCCOP - University of Illinois at Chicago|
|Chicago, Illinois, United States, 60612|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|Rush-Presbyterian-St. Luke's Medical Center|
|Chicago, Illinois, United States, 60612-3824|
|CCOP - Central Illinois|
|Decatur, Illinois, United States, 62794-9640|
|CCOP - Evanston|
|Evanston, Illinois, United States, 60201|
|CCOP - Carle Cancer Center|
|Urbana, Illinois, United States, 61801|
|United States, Indiana|
|Indiana University Cancer Center|
|Indianapolis, Indiana, United States, 46202-5289|
|Saint Joseph Regional Medical Center|
|South Bend, Indiana, United States, 46617|
|United States, Iowa|
|Holden Comprehensive Cancer Center at University of Iowa|
|Iowa City, Iowa, United States, 52242-1002|
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|United States, Michigan|
|CCOP - Michigan Cancer Research Consortium|
|Ann Arbor, Michigan, United States, 48106|
|CCOP - Grand Rapids|
|Grand Rapids, Michigan, United States, 49503|
|CCOP - Kalamazoo|
|Kalamazoo, Michigan, United States, 49007-3731|
|United States, Minnesota|
|CCOP - Metro-Minnesota|
|Saint Louis Park, Minnesota, United States, 55416|
|United States, Mississippi|
|University of Mississippi Medical Center|
|Jackson, Mississippi, United States, 39216-4505|
|United States, Missouri|
|Ellis Fischel Cancer Center at University of Missouri - Columbia|
|Columbia, Missouri, United States, 65203|
|CCOP - Kansas City|
|Kansas City, Missouri, United States, 64131|
|CCOP - Cancer Research for the Ozarks|
|Springfield, Missouri, United States, 65807|
|United States, Nebraska|
|CCOP - Missouri Valley Cancer Consortium|
|Omaha, Nebraska, United States, 68106|
|United States, New Jersey|
|Cooper University Hospital|
|Camden, New Jersey, United States, 08103-1489|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Long Island Cancer Center at Stony Brook University Hospital|
|Stony Brook, New York, United States, 11790-7775|
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7295|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Charles M. Barrett Cancer Center at University Hospital|
|Cincinnati, Ohio, United States, 45267-0526|
|Ireland Cancer Center|
|Cleveland, Ohio, United States, 44106|
|Arthur G. James Cancer Hospital - Ohio State University|
|Columbus, Ohio, United States, 43210-1240|
|United States, Oregon|
|CCOP - Columbia River Oncology Program|
|Portland, Oregon, United States, 97225|
|United States, Pennsylvania|
|Abington Memorial Hospital|
|Abington, Pennsylvania, United States, 19001-3788|
|CCOP - Geisinger Clinic and Medical Center|
|Danville, Pennsylvania, United States, 17822-2001|
|Penn State Cancer Institute at Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033-0850|
|Abramson Cancer Center at University of Pennsylvania Medical Center|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|Kimmel Cancer Center at Thomas Jefferson University - Philadelphia|
|Philadelphia, Pennsylvania, United States, 19107|
|Pittsburgh, Pennsylvania, United States, 15213-3180|
|United States, Tennessee|
|Southeast Gynecologic Oncology Associates|
|Knoxville, Tennessee, United States, 37917|
|Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center|
|Nashville, Tennessee, United States, 37232-2516|
|United States, Texas|
|University of Texas Medical Branch|
|Galveston, Texas, United States, 77555-0587|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|CCOP - Scott and White Hospital|
|Temple, Texas, United States, 76508|
|United States, Vermont|
|Fletcher Allen Health Care - Medical Center Campus|
|Burlington, Vermont, United States, 05401|
|United States, Wisconsin|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792-6188|
|Kagoshima City Hospital|
|Kagoshima City, Japan, 892-8580|
|Study Chair:||D. Scott McMeekin, MD||Oklahoma University Cancer Institute|