Epoetin Beta in Treating Anemia in Patients With Cervical Cancer
RATIONALE: Epoetin beta may stimulate red blood cell production to prevent or control anemia in patients treated with chemotherapy and radiation therapy.
PURPOSE: Randomized phase IV trial to determine the effectiveness of epoetin beta in treating anemia in patients who are receiving cisplatin and radiation therapy for stage IIB, stage III, or stage IVA cervical cancer.
Biological: epoetin beta
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||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)|
- Number of treatment failures within 6 months after beginning radiochemotherapy (RCT) (stage I)
- Overall survival after RCT (stage II)
- Progression/relapse-free survival
- Overall response rate to RCT
- Overall survival after RCT (stage I)
- Frequency and localization of relapses and/or metastases
- Change in hemoglobin from baseline during therapy
- Quality of life as assessed by the Functional Assessment of Cancer Therapy-Anemia
- Type, frequency, and degree of adverse events
- Vital signs
- Number of treatment failures within 6 months after beginning RCT (stage II)
|Study Start Date:||July 2002|
|Study Completion Date:||June 2007|
- 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 these regimens.
- 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 I.
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 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00046969
|Martin Luther Universitaet|
|Halle, Germany, D-06097|
|Study Chair:||Heinz Koelbl, MD||Martin-Luther-Universität Halle-Wittenberg|