Radiation Therapy Compared With Combination Chemotherapy in Treating Patients With Cancer of the Uterus
- Conditions
- Sarcoma
- Registration Number
- NCT00002546
- Lead Sponsor
- Gynecologic Oncology Group
- 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 whether radiation therapy is more effective than combination chemotherapy in treating patients with cancer of the uterus.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to combination chemotherapy in treating patients with cancer of the uterus.
- Detailed Description
OBJECTIVES:
* Compare the survival, progression-free interval, and failure patterns in patients with optimally debulked stage I-IV carcinosarcoma of the uterus treated with whole abdominal radiotherapy vs ifosfamide and cisplatin.
* Compare the incidence and type of acute and late adverse events observed with these treatment regimens in this patient population.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
* Arm I: Patients receive whole abdominal radiotherapy 5 days a week for 4 weeks, followed by radiotherapy boost to the pelvis 5 days a week for 2.2 weeks.
* Arm II: Patients receive cisplatin IV followed by ifosfamide IV over 1 hour on days 1-4. Treatment continues every 3 weeks for 3 courses.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 216 patients will be accrued for this study within 6 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 216
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (64)
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
CCOP - Western Regional, Arizona
🇺🇸Phoenix, Arizona, United States
Women's Cancer Center - Los Gatos
🇺🇸Los Gatos, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
🇺🇸Orange, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
University of Miami Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
MBCCOP - University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
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