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

Primary Purpose

Cervical Cancer, Anemia

Status
Suspended
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Blood transfusion
Blood transfusion
Sponsored by
Tri-Service General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cervical Cancer focused on measuring Haemoglobin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Maintain hemoglobin level above 120 g/L

    Maintain hemoglobin level above 100 g/L

    Arm Description

    Hemoglobin level from 120 g/L to 130 g/L

    Hemoglobin level from 100 g/L to 110 g/L

    Outcomes

    Primary Outcome Measures

    The impact of maintaining hemoglobin levels above 120 g/L versus above 100 g/L

    Secondary Outcome Measures

    Full Information

    First Posted
    June 15, 2009
    Last Updated
    June 18, 2009
    Sponsor
    Tri-Service General Hospital
    Collaborators
    National Taiwan University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00921635
    Brief Title
    A Study to Evaluate the Impact of Maintaining Hemoglobin Levels in Anemic Patients With Carcinoma of the Cervix
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2009
    Overall Recruitment Status
    Suspended
    Study Start Date
    April 2008 (undefined)
    Primary Completion Date
    May 2011 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Tri-Service General Hospital
    Collaborators
    National Taiwan University Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Cancer, Anemia
    Keywords
    Haemoglobin

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    2 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Maintain hemoglobin level above 120 g/L
    Arm Type
    Experimental
    Arm Description
    Hemoglobin level from 120 g/L to 130 g/L
    Arm Title
    Maintain hemoglobin level above 100 g/L
    Arm Type
    Active Comparator
    Arm Description
    Hemoglobin level from 100 g/L to 110 g/L
    Intervention Type
    Procedure
    Intervention Name(s)
    Blood transfusion
    Intervention Description
    Blood transfusion to maintain hemoglobin level above 120 g/L
    Intervention Type
    Procedure
    Intervention Name(s)
    Blood transfusion
    Intervention Description
    Blood transfusion to maintain hemoglobin level above 100 g/L
    Primary Outcome Measure Information:
    Title
    The impact of maintaining hemoglobin levels above 120 g/L versus above 100 g/L
    Time Frame
    5 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yee-Min Jen
    Organizational Affiliation
    Randiation Oncology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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