A Study to Evaluate the Impact of Maintaining Hemoglobin Levels in Anemic Patients With Carcinoma of the Cervix

Phase 3

Suspended

• Conditions: Cervical Cancer; Anemia
• Interventions: Procedure: Blood transfusion

• Registration Number: NCT00921635
• Lead Sponsor: Tri-Service General Hospital

Brief Summary

The purpose of this study is to assess the feasibility, safety and short term effects on health related quality of life, of maintaining hemoglobin from 120 to 130 g/L versus from 100 to 110 g/L, with red cell concentrate (RCC) transfusion, in women having chemo-radiation for cancer of the cervix.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Status Verified: 2009-06
• Study First Submitted: 2009-06-15
• Study First Submitted QC: 2009-06-15
• Study First Posted: 2009-06-16
• Last Update Submitted: 2009-06-18
• Last Update Posted: 2009-06-19
• Primary Completion: 2011-05

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 2

Inclusion Criteria

• Previously untreated cervix cancer
• FIGO stage IB2, II, IIIB, IVA
• Suitable for treatment with radical intent using concurrent cisplatin and pelvic radiation

Exclusion Criteria

• Hemoglobin level above 125g/L
• Lower one-third vaginal involvement
• Para-aortic lymphadenopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maintain hemoglobin level above 120 g/L	Blood transfusion	Hemoglobin level from 120 g/L to 130 g/L
Maintain hemoglobin level above 100 g/L	Blood transfusion	Hemoglobin level from 100 g/L to 110 g/L

Primary Outcome Measures

Name	Time	Method
The impact of maintaining hemoglobin levels above 120 g/L versus above 100 g/L	5 years