NCT00921635

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.

Trial Health

20
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
2

participants targeted

Target at below P25 for phase_3

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Last Updated

June 19, 2009

Status Verified

June 1, 2009

Enrollment Period

3.1 years

First QC Date

June 15, 2009

Last Update Submit

June 18, 2009

Conditions

Cervical CancerAnemia

Keywords

Haemoglobin

Outcome Measures

Primary Outcomes (1)

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

    5 years

Study Arms (2)

Maintain hemoglobin level above 120 g/L

EXPERIMENTAL

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

Procedure: Blood transfusion

Maintain hemoglobin level above 100 g/L

ACTIVE COMPARATOR

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

Procedure: Blood transfusion

Interventions

Blood transfusionPROCEDURE

Blood transfusion to maintain hemoglobin level above 120 g/L

Maintain hemoglobin level above 120 g/L

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previously untreated cervix cancer
  • FIGO stage IB2, II, IIIB, IVA
  • Suitable for treatment with radical intent using concurrent cisplatin and pelvic radiation

You may not qualify if:

  • Hemoglobin level above 125g/L
  • Lower one-third vaginal involvement
  • Para-aortic lymphadenopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Uterine Cervical NeoplasmsAnemia

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Yee-Min Jen

    Randiation Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 15, 2009

First Posted

June 16, 2009

Study Start

April 1, 2008

Primary Completion

May 1, 2011

Last Updated

June 19, 2009

Record last verified: 2009-06