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

NCT ID: NCT00548821

Last Updated: 2008-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

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.

Detailed Description

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Conditions

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Locally Advanced Cervical Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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2

ARM 2: Weekly cisplatin 40mg/m2, concurrent with radiotherapy.

Group Type EXPERIMENTAL

Cisplatin

Intervention Type DRUG

1

ARM 1: 5-day 3 weekly cisplatin 20mg/m2 for 5 days, concurrent with radiotherapy

Group Type EXPERIMENTAL

Cisplatin

Intervention Type DRUG

Interventions

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Cisplatin

Intervention Type DRUG

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
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National University Hospital, Singapore

OTHER

Sponsor Role lead

Responsible Party

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National University Hospital, Singapore

Principal Investigators

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Johann Tang

Role: PRINCIPAL_INVESTIGATOR

NUH

Locations

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National University Hospital

Singapore, , Singapore

Site Status

Countries

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Singapore

Central Contacts

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Johann Tang

Role: CONTACT

Phone: 677204870

Email: [email protected]

Other Identifiers

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Cervix Cancer Research

Identifier Type: -

Identifier Source: org_study_id