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NCT00921635 Clinical Trial

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

Cervical Cancer Clinical Trial

— HOSTT  

Official title:
A Phase III Study to Evaluate the Impact of Maintaining Haemoglobin Levels Above 120g/L Verses Above 100g/L in Anaemic Patients With Carcinoma of the Cervix Receiving Concurrent Cisplatin and Radiation Therapy

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT00921635
Other study ID # ANZGOG0401
Secondary ID TSGHIRB095-05-04
Status Suspended
Phase Phase 3
First received June 15, 2009
Last updated June 18, 2009
Start date April 2008

Study information
Verified date June 2009
Source Tri-Service General Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Suspended
Enrollment 2
Est. completion date
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Procedure:
• Blood transfusion
Blood transfusion to maintain hemoglobin level above 120 g/L
• Blood transfusion
Blood transfusion to maintain hemoglobin level above 100 g/L

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Tri-Service General Hospital National Taiwan University Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary The impact of maintaining hemoglobin levels above 120 g/L versus above 100 g/L 5 years No
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