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A Phase III Randomized Trial Between 5 Day 3 Weekly and Weekly Cisplatin Based Chemotherapy for Patients With Locally Advanced Cervical Cancer


Phase 3
21 Years
N/A
Not Enrolling
Female
Locally Advanced Cervical Cancer

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Trial Information

A Phase III Randomized Trial Between 5 Day 3 Weekly and Weekly Cisplatin Based Chemotherapy for Patients With Locally Advanced Cervical Cancer


Inclusion Criteria:



- stage IB2-IVA , histological proven cervical carcinoma

- no previous diagnosis of carcinoma

- no prior history of chemotherapy or radiotherapy

- ECOG less than or equal to 2

- Above 21 years old

- medically fit for radical concurrent Cisplatin based chemotherapy and radiotherapy

- Hemoglobin >10g/dL

- Adequate hematological, renal and hepatic function according to all of the following
laboratory values:

- Absolute neutrophil count ≥ 1.5 ×109/l

- Platelets ≥ 100 ×109/l

- Serum creatinine ≤ 1.5 times upper limit of laboratory normal

- Total serum bilirubin ≤ 1.5 times upper limit of laboratory normal

- ASAT(AST) or ALAT(ALT) ≤ 2.5 times upper limit of laboratory normal

- Alkaline phosphatase of ≤ 2.5 times upper limit of laboratory normal

Exclusion Criteria:

- Age below 21

- Presence of known HIV infection, chronic hepatitis B or hepatitis C infection

- Psychological, familial, sociological, or geographical condition that would preclude
study participation

- Prior (within the last 3 years) or simultaneous malignancies (other then cutaneous
basal cell carcinoma or non-invasive tumors)

- Patients with the following histologies are excluded: small cell, carcinoid, glassy
cell, clear cell and adenoid cystic.

- Life expectancy < 6 months

- Patients with insulin dependent diabetes

- Prior tumor-directed surgery

- Previous systemic chemotherapy or pelvic radiation therapy

- As radiation and cytotoxic agents are contraindicated in pregnancy, pregnant women
are ineligible and those of childbearing potential should use contraception

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary aim of this research protocol is to compare if there is a difference in progression free survival between weekly versus 5-day 3 weekly cisplatin based chemotherapy regimen in women with locally advanced cervical cancer.

Principal Investigator

Johann Tang

Investigator Role:

Principal Investigator

Investigator Affiliation:

NUH

Authority:

Singapore: Health Sciences Authority

Study ID:

Cervix Cancer Research

NCT ID:

NCT00548821

Start Date:

Completion Date:

Related Keywords:

  • Locally Advanced Cervical Cancer
  • Uterine Cervical Neoplasms

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