Randomised Study to Compare the Effect of r-Hu-EPO Administration With Transfusion of Red Blood Cell Concentrates and Also With the Administration of Polyvitamins in Anemic and Tired Patients Presenting a Bad Prognostic in Middle Course

NCT ID: NCT00180999

Last Updated: 2006-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Brief Summary

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Randomised study to compare the effect of r-Hu-EPO administration with transfusion of Red Blood cell concentrates and also with the administration of polyvitamins in anemic and tired patients presenting a bad prognostic in middle course.

Detailed Description

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Conditions

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- Medico-Economic Aspects (Evaluation of Medical Costs Related to the Three Strategies and Evaluation of Cost/Efficacy)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Erythropoiétine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Both sexes
* 18-70 yrs
* metastatic or locally advanced cancer
* Life expectancy \> 3 months
* hemoglobin between 7 and 10 g/100ml
* no contraindication to r-Hu-EPO
* with written informed consent at entry time
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role lead

Principal Investigators

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Valérie LAPIERRE, MD

Role: PRINCIPAL_INVESTIGATOR

Gustave Roussy, Cancer Campus, Grand Paris

Locations

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Institut Gustave-Roussy

Villejuif, , France

Site Status

Countries

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France

Other Identifiers

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CSET 98/663

Identifier Type: -

Identifier Source: secondary_id

TUMFATIGUE

Identifier Type: -

Identifier Source: org_study_id