Management Of Anemia Under RadioChemotherapy (MARCH): An Open, Randomized Multicenter Study Of The Effect Of NeoRecormon On Treatment Outcome In Patients With Advanced Cervical Cancer Stage IIB -IVA Treated With Primary Simultaneous Radiochemotherapy (Radiotherapy Plus Cisplatin)
- Compare the effectiveness of epoetin beta vs standard care for anemia management, in
terms of increased hemoglobin levels and the correlation with reduced relapse/treatment
failure rate, in patients with stage IIB, III, or IVA cervical cancer treated with
cisplatin and radiotherapy.
- Compare the safety of these regimens in these patients.
- Compare the relapse-free and overall survival of patients treated with these regimens.
- Compare the frequency and localization of relapses and metastases in patients treated
with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Compare the type, frequency, and degree of adverse events in patients treated with
- Compare the overall response rate in patients treated with these regimens.
OUTLINE: This is a randomized, open-label, parallel-group, multicenter study. Patients are
stratified according to country, disease stage, and brachytherapy technique. Patients are
randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo radiotherapy 5 days a week for 6 weeks. Patients also undergo
high-dose rate, low-dose rate, or boost brachytherapy. Patients receive cisplatin IV
beginning on day 1 of radiotherapy and continuing weekly for 6 weeks. Patients also
receive epoetin beta subcutaneously 3 times a week beginning 2 weeks before
radiotherapy and continuing for 8 weeks.
- Arm II: Patients undergo radiotherapy and brachytherapy and receive cisplatin as in arm
Quality of life is assessed at baseline, after the last treatment, and at 3 months.
Patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 80-450 patients will be accrued for this study within 4-22.5
Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care
Number of treatment failures within 6 months after beginning radiochemotherapy (RCT) (stage I)
Heinz Koelbl, MD
United States: Federal Government