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
  Purpose

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.


Condition Intervention Phase
Cervical Cancer
Anemia
Procedure: Blood transfusion
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Tri-Service General Hospital:

Primary Outcome Measures:
  • The impact of maintaining hemoglobin levels above 120 g/L versus above 100 g/L [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: April 2008
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Maintain hemoglobin level above 120 g/L
Hemoglobin level from 120 g/L to 130 g/L
Procedure: Blood transfusion
Blood transfusion to maintain hemoglobin level above 120 g/L
Active Comparator: Maintain hemoglobin level above 100 g/L
Hemoglobin level from 100 g/L to 110 g/L
Procedure: Blood transfusion
Blood transfusion to maintain hemoglobin level above 100 g/L

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00921635

Sponsors and Collaborators
Tri-Service General Hospital
National Taiwan University Hospital
Investigators
Principal Investigator: Yee-Min Jen Randiation Oncology
  More Information

No publications provided

Responsible Party: Yee-Min Jen/Head of the department of Radiation oncology, Radiation oncology of Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT00921635     History of Changes
Other Study ID Numbers: ANZGOG0401, TSGHIRB095-05-044
Study First Received: June 15, 2009
Last Updated: June 18, 2009
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Tri-Service General Hospital:
Haemoglobin

Additional relevant MeSH terms:
Anemia
Carcinoma
Uterine Cervical Neoplasms
Hematologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 16, 2014