Spots Global Cancer Trial Database for Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Stage I Cancer of the Cervix
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Trial Identification
Brief Title: Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Stage I Cancer of the Cervix
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 ID: NCT00054067
Conditions
Study Description
Brief Summary: 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.
Detailed Description: OBJECTIVES: * 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States
CCOP - Western Regional, Arizona, Phoenix, Arizona, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Women's Cancer Center at Community Hospital of Los Gatos, Los Gatos, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center, Orange, California, United States
Yale Comprehensive Cancer Center, New Haven, Connecticut, United States
CCOP - Christiana Care Health Services, Newark, Delaware, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois, United States
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
CCOP - Central Illinois, Decatur, Illinois, United States
CCOP - Evanston, Evanston, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
Saint Joseph Regional Medical Center, South Bend, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States
CCOP - Grand Rapids, Grand Rapids, Michigan, United States
CCOP - Kalamazoo, Kalamazoo, Michigan, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, United States
CCOP - Kansas City, Kansas City, Missouri, United States
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
Cooper University Hospital, Camden, New Jersey, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Long Island Cancer Center at Stony Brook University Hospital, Stony Brook, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, United States
Ireland Cancer Center, Cleveland, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States
CCOP - Columbia River Oncology Program, Portland, Oregon, United States
Abington Memorial Hospital, Abington, Pennsylvania, United States
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Abramson Cancer Center at University of Pennsylvania Medical Center, Philadelphia, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States
Magee-Womens Hospital, Pittsburgh, Pennsylvania, United States
Southeast Gynecologic Oncology Associates, Knoxville, Tennessee, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville, Tennessee, United States
University of Texas Medical Branch, Galveston, Texas, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
CCOP - Scott and White Hospital, Temple, Texas, United States
Fletcher Allen Health Care - Medical Center Campus, Burlington, Vermont, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
Kagoshima City Hospital, Kagoshima City, , Japan
Contact Details
Name: D. Scott McMeekin, MD
Affiliation: Oklahoma University Cancer Institute
Role: STUDY_CHAIR
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