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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Locally Advanced Cervical Cancer

Intervention / Treatment
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* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br>ARM 2: Weekly cisplatin 40mg/m2, concurrent with radiotherapy. | Drug: Cisplatin<br> <br> |
| Experimental: 1<br>ARM 1: 5-day 3 weekly cisplatin 20mg/m2 for 5 days, concurrent with radiotherapy | Drug: Cisplatin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary aims are to compare quality of life assessment of patients and their carers as well as toxicity profiles both acute and late. |  |  |