Radiation Therapy and Cisplatin With or Without Epoetin Alfa in Treating Patients With Cervical Cancer and Anemia
RATIONALE: Drugs used in chemotherapy 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. Epoetin alfa may stimulate red blood cell production to treat anemia in patients who have received chemotherapy and/or radiation therapy for cervical cancer.
PURPOSE: Randomized phase III trial to study the effectiveness of epoetin alfa in treating anemia in patients who have cervical cancer.
Drug/Agent Toxicity by Tissue/Organ
Biological: epoetin alfa
Procedure: quality-of-life assessment
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||Phase III Trial to Evaluate the Efficacy of Maintaining Hemoglobin Levels Above 120 G/L With Erythropoietin Versus Above 100 G/L Without Erythropoietin in Anemic Patients Receiving Concurrent Radiation and Cisplatin for Cervical Cancer|
|Study Start Date:||August 2001|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
- Assess the efficacy of raising and maintaining hemoglobin (Hgb) levels above 12.0 g/dL with epoetin alfa vs maintaining Hgb levels above 10.0 g/dL without epoetin alfa on progression-free survival, overall survival, and local control in anemic patients with cervical cancer receiving concurrent radiotherapy and cisplatin.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized study. Patients are stratified according to stage (IIB vs IIIB vs IVA), method of brachytherapy (low-dose vs high-dose), and surgical staging of para-aortic nodes (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo radiotherapy comprising pelvic external beam radiotherapy daily five days a week for 5 weeks, followed by either 1 or 2 implants of low-dose rate intracavitary brachytherapy or 5 fractions of high-dose rate intracavitary brachytherapy, followed by 3-5 days of parametrial boost radiotherapy. Patients receive cisplatin IV concurrently with pelvic external beam radiotherapy on days 1, 8, 15, 22, 29, and once during the week of parametrial boost radiotherapy.
- Arm II: Patients undergo radiotherapy and chemotherapy as in arm I. Additionally, patients receive epoetin alfa subcutaneously once weekly concurrently with radiotherapy and chemotherapy.
Quality of life is assessed at baseline, during weeks 3 and 6, within 1 week of last brachytherapy, and every 3 months for 2 years.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 460 patients will be accrued for this study within 3.5 years.
Show 44 Study Locations
|Study Chair:||Gillian M. Thomas, BSc, MD, FRCPC, FRCR (Hon)||Odette Cancer Centre at Sunnybrook|
|Study Chair:||Peter S. Craighead, MD||Tom Baker Cancer Centre - Calgary|