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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase IV Randomized Study of Epoetin beta for Anemia Management in Patients With Stage IIB, III, or IVA Cervical Cancer Treated With Cisplatin and Radiotherapy

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase IV Supportive care, Treatment Completed Over 18 Pharmaceutical / Industry AGOSG-OVAR-MO16375-MARCH EU-20217, ROCHE-MO16375, ROCHE-RO2053859, NCT00046969

Trial Description

Purpose:

Epoetin beta may stimulate red blood cell production to prevent or control anemia in patients treated with chemotherapy and radiation therapy.

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.

Eligibility:

Eligibility criteria include the following:

• At least 19 years old
• No distant metastases
• At least 3 months since biological therapy
• No previous radiation therapy for cervical cancer
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned to one of two groups. Patients in group one will undergo radiation therapy 5 days a week for 6 weeks. They will also undergo internal radiation. Beginning on day 1 of radiation therapy, patients will receive an infusion of cisplatin once a week for 6 weeks. They will also receive injections of epoetin beta three times a week beginning 2 weeks before radiation therapy and continuing for 8 weeks. Patients in group two will undergo radiation therapy and internal radiation and receive cisplatin as in group one. Quality of life will be assessed periodically. Patients will be evaluated every 3 months for 2 years and every 6 months thereafter.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

AGO Ovarian Cancer Study Group

Heinz Koelbl, MD, Protocol chair		Ph: 49-345-557-1847

Registry Information
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)
Trial Start Date		2002-07-10
Registered in ClinicalTrials.gov		NCT00046969
Date Submitted to PDQ		2002-02-12
Information Last Verified		2007-03-28

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