- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00548821
Randomized Trial Between Weekly and 5 Day 3 Weekly Cisplatin for Cervical Cancer
May 13, 2008 updated by: National University Hospital, Singapore
A Phase III Randomized Trial Between 5 Day 3 Weekly and Weekly Cisplatin Based Chemotherapy for Patients With Locally Advanced Cervical Cancer
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.
Study Overview
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Johann Tang
- Phone Number: 677204870
- Email: Johann_Tang@mail.nhg.com.sg
Study Locations
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Singapore, Singapore, 119074
- National University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 2
ARM 2: Weekly cisplatin 40mg/m2, concurrent with radiotherapy.
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Experimental: 1
ARM 1: 5-day 3 weekly cisplatin 20mg/m2 for 5 days, concurrent with radiotherapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
|
Secondary Outcome Measures
Outcome Measure |
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The secondary aims are to compare quality of life assessment of patients and their carers as well as toxicity profiles both acute and late.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Johann Tang, NUH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
October 23, 2007
First Submitted That Met QC Criteria
October 23, 2007
First Posted (Estimate)
October 24, 2007
Study Record Updates
Last Update Posted (Estimate)
May 15, 2008
Last Update Submitted That Met QC Criteria
May 13, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cervix Cancer Research
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Locally Advanced Cervical Cancer
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Washington University School of MedicineNational Cancer Institute (NCI)RecruitingCervical Cancer | Pancreatic Cancer | Pancreas Cancer | Locally Advanced Cervical Carcinoma | Locally Advanced Cervical Cancer | Cancer of the Pancreas | Locally Advanced Pancreatic Carcinoma | Locally Advanced Pancreatic Cancer | Cancer of the Cervix | Locally Advanced Pancreas CancerUnited States
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Assiut UniversityNot yet recruitingLocally Advanced Cervical Carcinoma
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Fudan UniversityAmoy Diagnostics Co., LTDRecruitingLocally Advanced Cervical CancerChina
-
Shanghai Zhongshan HospitalRecruitingLocally Advanced Cervical CancerChina
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Fondazione Policlinico Universitario Agostino Gemelli...Merck Sharp & Dohme LLCRecruitingLocally Advanced Cervical CancerItaly
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Washington University School of MedicineWithdrawn
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University of Texas Southwestern Medical CenterTerminatedLocally Advanced Cervical CancerUnited States
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Barts & The London NHS TrustCompletedLocally Advanced Cervical CancerUnited Kingdom
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Chongqing University Cancer HospitalNot yet recruitingLocally Advanced Cervical CancerChina
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Academisch Medisch Centrum - Universiteit van Amsterdam...CompletedLocally Advanced Cervical CancerNetherlands
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