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

June 18, 2009 updated by: Tri-Service General Hospital

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Procedure: Blood transfusion
Blood transfusion to maintain hemoglobin level above 100 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 120 g/L
Procedure: Blood transfusion
Blood transfusion to maintain hemoglobin level above 100 g/L

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The impact of maintaining hemoglobin levels above 120 g/L versus above 100 g/L
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tri-Service General Hospital

Collaborators

National Taiwan University Hospital

Investigators

  • Principal Investigator: Yee-Min Jen, Randiation Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Anticipated)

May 1, 2011

Study Registration Dates

First Submitted

June 15, 2009

First Submitted That Met QC Criteria

June 15, 2009

First Posted (Estimate)

June 16, 2009

Study Record Updates

Last Update Posted (Estimate)

June 19, 2009

Last Update Submitted That Met QC Criteria

June 18, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANZGOG0401
  • TSGHIRB095-05-044

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cervical Cancer

Clinical Trials on Blood transfusion

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe