Trial Information

Summary: (MARCH Study) - A Study of NeoRecormon (Epoetin Beta) in Patients With Advanced Cervical Cancer

Status: Completed

Protocol Number: MO16375

Sponsor: Hoffmann-La Roche AG

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the effect of NeoRecormon and simultaneous radiochemotherapy on progression-free survival in patients with stage IIB to IVA cervical cancer

Brief Summary: This study will compare the outcome of treatment with or without NeoRecormon in patients with advanced cervical cancer treated with primary simultaneous radiochemotherapy. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals. Target sample size is 74.

Study Phase: III

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• Control: Active
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Anemia

Intervention Type: Drug

Intervention Name: epoetin beta[NeoRecormon]

Primary Outcome: 1. Efficacy: Number of treatment failures

Key Secondary Outcomes: 1. Efficacy: Progression-/relapse-free survival, overall response rate to RCT, frequency and localization of relapses/metastases, Hb change from baseline, QOL. Safety: Adverse events, lab parameters, vital signs.

Inclusion Criteria:

Exclusion Criteria:

Gender: Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 05/23/2005

Date Last Updated: 08/18/2008

Link To Trial Results

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Trial listings updated: September 2, 2008 at 1:44:30 PM