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

This study has suspended participant recruitment.
Sponsor:
Collaborator:
National Taiwan University Hospital
Information provided by:
Tri-Service General Hospital
ClinicalTrials.gov Identifier:
NCT00921635
First received: June 15, 2009
Last updated: June 18, 2009
Last verified: June 2009

June 15, 2009
June 18, 2009
April 2008
May 2011   (final data collection date for primary outcome measure)
The impact of maintaining hemoglobin levels above 120 g/L versus above 100 g/L [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00921635 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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A Study to Evaluate the Impact of Maintaining Hemoglobin Levels in Anemic Patients With Carcinoma of the Cervix
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Cervical Cancer
  • Anemia
  • Procedure: Blood transfusion
    Blood transfusion to maintain hemoglobin level above 120 g/L
  • Procedure: Blood transfusion
    Blood transfusion to maintain hemoglobin level above 100 g/L
  • Experimental: Maintain hemoglobin level above 120 g/L
    Hemoglobin level from 120 g/L to 130 g/L
    Intervention: Procedure: Blood transfusion
  • Active Comparator: Maintain hemoglobin level above 100 g/L
    Hemoglobin level from 100 g/L to 110 g/L
    Intervention: Procedure: Blood transfusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
2
Not Provided
May 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00921635
ANZGOG0401, TSGHIRB095-05-044
Yes
Yee-Min Jen/Head of the department of Radiation oncology, Radiation oncology of Tri-Service General Hospital
Tri-Service General Hospital
National Taiwan University Hospital
Principal Investigator: Yee-Min Jen Randiation Oncology
Tri-Service General Hospital
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP