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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00548821
• Date of registration: 23/10/2007
• Primary sponsor: National University Hospital, Singapore
• Public title: Randomized Trial Between Weekly and 5 Day 3 Weekly Cisplatin for Cervical Cancer
• Scientific title: A Phase III Randomized Trial Between 5 Day 3 Weekly and Weekly Cisplatin Based Chemotherapy for Patients With Locally Advanced Cervical Cancer
• Date of first enrolment: November 2007
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT00548821
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Singapore

Contacts

• Name: Johann Tang

• Name: Johann Tang
• Affiliation: NUH

Key inclusion & exclusion 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



Age minimum: 21 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Locally Advanced Cervical Cancer

Intervention(s)

Drug: Cisplatin

Primary Outcome(s)

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(s)

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

Secondary ID(s)

Cervix Cancer Research

Source(s) of Monetary Support

Please refer to primary and secondary sponsors