Treatment of Patients With Stage IB2 Carcinoma of the Cervix: A Randomized Comparison of Radical Hysterectomy and Tailored Chemo-Radiation Versus Primary Chemo-Radiation
- Compare progression-free survival and survival of patients with stage IB2 carcinoma of
the cervix after radical hysterectomy with tailored chemoradiotherapy vs primary
- 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
- 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
- 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
- Group B: Patients receive treatment as in group 2 above without intracavity
- 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
Quality of life is assessed at baseline, during week 5 of therapy, and then at 3, 6, and 12
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
PROJECTED ACCRUAL: A total of 740 patients (370 per treatment arm) will be accrued for this
study within 7.5 years.
Allocation: Randomized, Primary Purpose: Treatment
D. Scott McMeekin, MD
Oklahoma University Cancer Institute
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|
|Walter Reed Army Medical Center||Washington, District of Columbia 20307-5000|
|Rush-Presbyterian-St. Luke's Medical Center||Chicago, Illinois 60612|
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|
|University of Mississippi Medical Center||Jackson, Mississippi 39216-4505|
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|Ireland Cancer Center||Cleveland, Ohio 44106-5065|
|Arthur G. James Cancer Hospital - Ohio State University||Columbus, Ohio 43210|
|Abington Memorial Hospital||Abington, Pennsylvania 19001|
|CCOP - Kansas City||Kansas City, Missouri 64131|
|CCOP - Missouri Valley Cancer Consortium||Omaha, Nebraska 68131|
|CCOP - Christiana Care Health Services||Wilmington, Delaware 19899|
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|CCOP - Kalamazoo||Kalamazoo, Michigan 49007-3731|
|CCOP - Metro-Minnesota||Saint Louis Park, Minnesota 55416|
|Yale Comprehensive Cancer Center||New Haven, Connecticut 06520-8028|
|CCOP - Michigan Cancer Research Consortium||Ann Arbor, Michigan 48106|
|Penn State Cancer Institute at Milton S. Hershey Medical Center||Hershey, Pennsylvania 17033-0850|
|University of Alabama at Birmingham Comprehensive Cancer Center||Birmingham, Alabama 35294-3300|
|CCOP - Central Illinois||Springfield, Illinois 62526|
|CCOP - Cancer Research for the Ozarks||Springfield, Missouri 65807|
|University of Texas Medical Branch||Galveston, Texas 77555-1329|
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|
|CCOP - Western Regional, Arizona||Phoenix, Arizona 85006-2726|
|Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center||Orange, California 92868|
|MBCCOP - University of Illinois at Chicago||Chicago, Illinois 60612|
|CCOP - Evanston||Evanston, Illinois 60201|
|Saint Joseph Regional Medical Center||South Bend, Indiana 46617|
|Holden Comprehensive Cancer Center at University of Iowa||Iowa City, Iowa 52242-1002|
|CCOP - Grand Rapids||Grand Rapids, Michigan 49503|
|Ellis Fischel Cancer Center at University of Missouri - Columbia||Columbia, Missouri 65203|
|Long Island Cancer Center at Stony Brook University Hospital||Stony Brook, New York 11790-7775|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|
|Charles M. Barrett Cancer Center at University Hospital||Cincinnati, Ohio 45267-0526|
|CCOP - Columbia River Oncology Program||Portland, Oregon 97225|
|CCOP - Geisinger Clinic and Medical Center||Danville, Pennsylvania 17822-2001|
|Kimmel Cancer Center at Thomas Jefferson University - Philadelphia||Philadelphia, Pennsylvania 19107|
|Southeast Gynecologic Oncology Associates||Knoxville, Tennessee 37917|
|Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center||Nashville, Tennessee 37232-2516|
|CCOP - Scott and White Hospital||Temple, Texas 76508|
|Cooper University Hospital||Camden, New Jersey 08103|
|Fletcher Allen Health Care - Medical Center Campus||Burlington, Vermont 05401|
|Abramson Cancer Center at University of Pennsylvania Medical Center||Philadelphia, Pennsylvania 19104|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|
|Magee-Womens Hospital||Pittsburgh, Pennsylvania 15213-3180|
|Women's Cancer Center at Community Hospital of Los Gatos||Los Gatos, California 95032|