Epoetin Beta in Treating Anemia in Patients With Cervical Cancer

Phase 4

Completed

• Conditions: Anemia; Cervical Cancer

• Registration Number: NCT00046969
• Lead Sponsor: AGO Study Group

Brief Summary

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.

Detailed Description

OBJECTIVES:

* 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.

Study Timeline

• Study Start: 2002-07
• Study First Submitted: 2002-10-03
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2007-03
• Study Completion: 2007-06
• Last Update Submitted: 2013-05-29
• Last Update Posted: 2013-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 450

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of treatment failures within 6 months after beginning radiochemotherapy (RCT) (stage I)
Overall survival after RCT (stage II)

Secondary Outcome Measures

Name	Time	Method
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
Safety
Vital signs
Number of treatment failures within 6 months after beginning RCT (stage II)

Trial Locations

Locations (1)

Martin Luther Universitaet; 🇩🇪 Halle, Germany