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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


Phase 3
18 Years
N/A
Not Enrolling
Female
Cervical Cancer, Anemia

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Yee-Min Jen

Investigator Role:

Principal Investigator

Investigator Affiliation:

Randiation Oncology

Authority:

Taiwan: Institutional Review Board

Study ID:

ANZGOG0401

NCT ID:

NCT00921635

Start Date:

April 2008

Completion Date:

Related Keywords:

  • Cervical Cancer
  • Anemia
  • Haemoglobin
  • Anemia
  • Carcinoma
  • Uterine Cervical Neoplasms

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