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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:
ClinicalTrials.gov Identifier:
NCT00921635
First Posted: June 16, 2009
Last Update Posted: June 19, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Taiwan University Hospital
Information provided by:
Tri-Service General Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00921635


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

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
First Submitted: June 15, 2009
First Posted: June 16, 2009
Last Update Posted: June 19, 2009
Last Verified: June 2009

Keywords provided by Tri-Service General Hospital:
Haemoglobin

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Benzocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents