Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Stage I Cancer of the Cervix - Article
Clinical Trial: Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Stage I Cancer of the Cervix
This study has been completed.
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: Randomizedphase 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.
|Condition||Treatment or Intervention||Phase|
|cervical adenocarcinoma |
cervical adenosquamous cell carcinoma
cervical squamous cell carcinoma
stage IB cervical cancer
| Drug: cisplatin |
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: radiation therapy
|Phase III |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Cervical Cancer; Soft Tissue Sarcoma
Study Type: Interventional
Study Design: Treatment
- 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.
- 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.
- 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.
- 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.
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
- Histologically confirmed stage IB2 invasive carcinoma of the uterine cervix of one of the following types:
- Squamous cell carcinoma
- Adenosquamous carcinoma
- Primary, previously untreated disease
- Exophytic cervical lesions greater than 4 cm in diameter OR
- Cervical expansion to greater than 4 cm in diameter, presumed to be the result of principal involvement with cancer
- No evidence of extrauterine disease other than pelvic lymph node involvement (by clinical and radiographic examinations)
- No para-aortic lymph nodal disease (suspected on CT scan, MRI, positron-emission tomography, or lymphangiogram) unless nodes are confirmed to be pathologically negative (by CT-guided biopsy or extraperitoneal lymph node dissection)
- Eligible for radical hysterectomy and lymph node dissection
PATIENT CHARACTERISTICS: Age
- 18 and over
- GOG 0-2
- Not specified
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.5 times normal
- SGOT no greater than 3 times normal
- Alkaline phosphatase no greater than 3 times normal
- Creatinine no greater than 2.0 mg/dL
- No renal abnormalities requiring modification of radiation fields
- Not pregnant
- Negative pregnancy test
- No septicemia or severe infection
- No other invasive malignancy with any evidence of disease within the past 5 years except nonmelanoma skin cancer
- No circumstances that would preclude study completion or required follow-up
PRIOR CONCURRENT THERAPY: Biologic therapy
- Not specified
- No prior chemotherapy
- Not specified
- No prior radiotherapy
- See Disease Characteristics
- No prior hysterectomy (total or subtotal)
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, 35294-3300, United States
CCOP - Western Regional, Arizona, Phoenix, Arizona, 85006-2726, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center, Orange, California, 92868, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, 90095-1740, United States
Women's Cancer Center at Community Hospital of Los Gatos, Los Gatos, California, 95032, United States
Yale Comprehensive Cancer Center, New Haven, Connecticut, 06520-8028, United States
CCOP - Christiana Care Health Services, Newark, Delaware, 19713, United States
District of Columbia
Walter Reed Army Medical Center, Washington, District of Columbia, 20307-5001, United States
CCOP - Carle Cancer Center, Urbana, Illinois, 61801, United States
CCOP - Central Illinois, Decatur, Illinois, 62794-9640, United States
CCOP - Evanston, Evanston, Illinois, 60201, United States
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, 60612, United States
Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois, 60612-3824, United States
University of Chicago Cancer Research Center, Chicago, Illinois, 60637-1470, United States
Indiana University Cancer Center, Indianapolis, Indiana, 46202-5289, United States
Saint Joseph Regional Medical Center, South Bend, Indiana, 46617, United States
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, 52242-1002, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland, 20892-1182, United States
CCOP - Grand Rapids, Grand Rapids, Michigan, 49503, United States
CCOP - Kalamazoo, Kalamazoo, Michigan, 49007-3731, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, 48106, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, 55416, United States
University of Mississippi Medical Center, Jackson, Mississippi, 39216-4505, United States
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, 65807, United States
CCOP - Kansas City, Kansas City, Missouri, 64131, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, 65203, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, 68106, United States
Cooper University Hospital, Camden, New Jersey, 08103-1489, United States
Long Island Cancer Center at Stony Brook University Hospital, Stony Brook, New York, 11790-7775, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, 27710, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, 27599-7295, United States
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, 43210-1240, United States
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, 45267-0526, United States
Ireland Cancer Center, Cleveland, Ohio, 44106, United States
CCOP - Columbia River Oncology Program, Portland, Oregon, 97225, United States
Abington Memorial Hospital, Abington, Pennsylvania, 19001-3788, United States
Abramson Cancer Center at University of Pennsylvania Medical Center, Philadelphia, Pennsylvania, 19104-4283, United States
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, 17822-2001, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, 19107, United States
Magee-Womens Hospital, Pittsburgh, Pennsylvania, 15213-3180, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, 17033-0850, United States
Southeast Gynecologic Oncology Associates, Knoxville, Tennessee, 37917, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville, Tennessee, 37232-2516, United States
CCOP - Scott and White Hospital, Temple, Texas, 76508, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, 77030-4009, United States
University of Texas Medical Branch, Galveston, Texas, 77555-0587, United States
Fletcher Allen Health Care - Medical Center Campus, Burlington, Vermont, 05401, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, 53792-6188, United States
Kagoshima City Hospital, Kagoshima City, 892-8580, Japan
Scott McMeekin, MD, Study Chair, Oklahoma University Medical Center
Record last reviewed: September 2004
Last Updated: October 13, 2004
Record first received: February 5, 2003
ClinicalTrials.gov Identifier: NCT00054067
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005