Overview

Randomized Trial Between Weekly and 5 Day 3 Weekly Cisplatin for Cervical Cancer

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Female
Summary
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. The secondary aims are to compare quality of life assessment of patients and their carers as well as toxicity profiles both acute and late.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National University Hospital, Singapore
Treatments:
Cisplatin
Criteria
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