Radiation Therapy and Cisplatin With or Without Amifostine for Patients With Stage IIIB or IVA Cervical Cancer
- Conditions
- Cervical CancerRadiation Toxicity
- Interventions
- Radiation: External beam radiation therapyRadiation: Intracavitary brachytherapy
- Registration Number
- NCT00012012
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Drugs such as amifostine may protect normal cells from the side effects of radiation therapy.
PURPOSE: Phase I/II trial to study the effectiveness of combining cisplatin and radiation therapy with or without amifostine in treating patients who have stage IIIB or stage IVA cancer of the cervix.
- Detailed Description
OBJECTIVES:
* Determine the feasibility and tolerability of external beam radiotherapy, brachytherapy, and cisplatin in patients with para-aortic or high common iliac lymph node-positive carcinoma of the uterine cervix.
* Determine the feasibility and tolerability of this regimen with the addition of amifostine in these patients.
* Determine the efficacy of these 2 regimens, in terms of improving pelvic and para-aortic tumor control and distant metastases, in these patients.
OUTLINE:
* Phase I: Patients undergo external beam radiotherapy to the pelvis and para-aortic region 5 days a week for 5 weeks. Patients also undergo either intracavitary low-dose rate (LDR) brachytherapy in 2 applications beginning within 2 weeks after completion of external beam radiotherapy at 2-3 week intervals or 6 fractions of high-dose rate intracavitary brachytherapy over 8 weeks beginning as early as week 2 of external beam radiotherapy. Patients also receive cisplatin IV over 1 hour weekly for 6 weeks concurrently with external beam radiotherapy and once with LDR brachytherapy. Phase II proceeds only if toxicity in phase I is within expected parameters.
* Phase II: Patients receive external beam radiotherapy, brachytherapy, and cisplatin as in phase I. Patients also receive amifostine subcutaneously daily just before external beam radiotherapy and cisplatin. Treatment continues for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 45
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Radiation therapy plus cisplatin External beam radiation therapy Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin. Radiation therapy plus cisplatin and amifostine Amifostine trihydrate Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate. Radiation therapy plus cisplatin and amifostine Intracavitary brachytherapy Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate. Radiation therapy plus cisplatin and amifostine External beam radiation therapy Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate. Radiation therapy plus cisplatin Intracavitary brachytherapy Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin. Radiation therapy plus cisplatin Cisplatin Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin. Radiation therapy plus cisplatin and amifostine Cisplatin Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate.
- Primary Outcome Measures
Name Time Method Rate of Acute Grade 3/4 Toxicity (Excluding Grade 3 Leukopenia) From start of treatment to 90 days To determine the feasibility and tolerance of extended-field external radiotherapy to the pelvis and para-aortic region and intracavitary irradiation combined with weekly cisplatin using the rate of acute grade 3/4 toxicity rate (excluding grade 3 leukopenia). The first part of this study was designed to determine the acute grade 3/4 toxicity rate (excluding grade 3 leukopenia), to have a starting point for the second part (second arm) of the study.
Number of Patients With Acute Grade 3/4 Toxicity (Excluding Grade 3 Leukopenia) From start of treatment to 90 days The second part of this study (second arm) was designed to detect a 40% relative reduction (absolute from 77% to 46%) in the acute grade 3/4 toxicity (excluding grade 3 leukopenia) rate, with the addition of amifostine. A one-sided alpha of 0.05 and 80% power required 16 evaluable patients to detect the hypothesized difference. If ≤ 8 had the toxicity, it would be concluded that adding amifostine decreased this toxicity rate by at least 40%.
- Secondary Outcome Measures
Name Time Method Distant Metastases From registration to date of distant mets or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years. Pelvic Tumor Control From registration to date of pelvic tumor failure or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.
Trial Locations
- Locations (17)
Cancer Treatment Center
🇺🇸Wooster, Ohio, United States
Akron City Hospital
🇺🇸Akron, Ohio, United States
Baptist Cancer Institute - Jacksonville
🇺🇸Jacksonville, Florida, United States
Florida Oncology Associates at Southside Cancer Center
🇺🇸Jacksonville, Florida, United States
Baptist Medical Center South
🇺🇸Jascksonville, Florida, United States
Florida Cancer Center - Palatka
🇺🇸Palatka, Florida, United States
Florida Oncology Associates
🇺🇸Orange Park, Florida, United States
Flagler Cancer Center
🇺🇸Saint Augustine, Florida, United States
Borgess Medical Center
🇺🇸Kalamazooaa, Michigan, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
🇺🇸Vineland, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
🇺🇸Marlton, New Jersey, United States
Integrated Community Oncology Network
🇺🇸Jacksonville Beach, Florida, United States
University Medical Center of Southern Nevada
🇺🇸Las Vegas, Nevada, United States
CCOP - Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Mercy Cancer Institute at Mercy Hospital
🇺🇸Pittsburgh, Pennsylvania, United States