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

Primary Purpose

Locally Advanced Cervical Cancer

Status
Unknown status
Phase
Phase 3
Locations
Singapore
Study Type
Interventional
Intervention
Cisplatin
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Cervical Cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

2

1

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

The secondary aims are to compare quality of life assessment of patients and their carers as well as toxicity profiles both acute and late.

Full Information

First Posted
October 23, 2007
Last Updated
May 13, 2008
Sponsor
National University Hospital, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT00548821
Brief Title
Randomized Trial Between Weekly and 5 Day 3 Weekly Cisplatin for Cervical Cancer
Official Title
A Phase III Randomized Trial Between 5 Day 3 Weekly and Weekly Cisplatin Based Chemotherapy for Patients With Locally Advanced Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National University Hospital, Singapore

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Cervical Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Experimental
Arm Description
ARM 2: Weekly cisplatin 40mg/m2, concurrent with radiotherapy.
Arm Title
1
Arm Type
Experimental
Arm Description
ARM 1: 5-day 3 weekly cisplatin 20mg/m2 for 5 days, concurrent with radiotherapy
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
The secondary aims are to compare quality of life assessment of patients and their carers as well as toxicity profiles both acute and late.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johann Tang
Phone
677204870
Email
Johann_Tang@mail.nhg.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johann Tang
Organizational Affiliation
NUH
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore

12. IPD Sharing Statement

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

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