Trial information
(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 type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
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:
- women >=18 years of age;
- advanced cervical cancer;
- no previous systemic antineoplastic therapy or radiotherapy for cervical cancer.
Exclusion criteria:
- therapy with epoetin or a related compound in the 3 months before study;
- women who are pregnant or lactating;
- administration of another investigational drug within 30 days preceding the first day of study treatment;
- bleeding requiring transfusion within past 3 months.
Gender: Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 05/23/2005
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Belgium
Germany
- Dresden
- Erlangen
- Goeppingen
- Halle
- Herne
- Homburg
- Marburg
- München
- Tübingen
- Wuppertal
Spain
Switzerland
Thailand
Turkey
United Kingdom
- Bristol
- Glasgow
- Nottingham
- Plymouth
