A Study to Evaluate the Impact of Maintaining Hemoglobin... | NCT00921635

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

NCT00921635

Sponsor

Tri-Service General Hospital (TSGH)

Status

Suspended

Last Update Posted

Jun 19, 2009Estimated

Enrollment

2Actual

Phase

Phase 3

Conditions

Cervical Cancer
Anemia

Interventions

Blood transfusion
Blood transfusion

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
TSGHIRB095-05-044

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

May 2011Estimated

Completion Date

Not provided

First Submitted Date

Jun 15, 2009

First Submission Date that Met QC Criteria

Jun 15, 2009

First Posted Date

Jun 16, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2009

Last Update Posted Date

Jun 19, 2009Estimated

Name	Class
National Taiwan University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Blood transfusion	Procedure	Blood transfusion to maintain hemoglobin level above 120 g/L	Maintain hemoglobin level above 120 g/L

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Yee-Min Jen	Randiation Oncology	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms
D000740	Anemia

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001803	Blood Transfusion

Ancestor Terms

ID	Term
D001691	Biological Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided