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

Locally Advanced Cervical Cancer Clinical Trial

Official title:

A Phase III Randomized Trial Between 5 Day 3 Weekly and Weekly Cisplatin Based Chemotherapy for Patients With Locally Advanced Cervical Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00548821
• Other study ID #: Cervix Cancer Research
• Status: Not yet recruiting
• Phase: Phase 3
• First received: October 23, 2007
• Last updated: May 13, 2008

Study information

• Verified date: May 2008
• Source: National University Hospital, Singapore
• Contact: Johann Tang
• Phone: 677204870
• Email: Johann_Tang[@]mail.nhg.com.sg
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Locally Advanced Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• Cisplatin

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The secondary aims are to compare quality of life assessment of patients and their carers as well as toxicity profiles both acute and late.