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

NCT00548821 | Unknown Phase 3 DMC

• 1 other identifier: Cervix Cancer Research
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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 Arms (2)

2

EXPERIMENTAL

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

Drug: Cisplatin

1

EXPERIMENTAL

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

Drug: Cisplatin

Interventions

Cisplatin DRUG

1; 2

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

Location

MeSH Terms

Interventions

Cisplatin

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Johann Tang

  NUH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johann Tang

CONTACT

677204870; Johann_Tang@mail.nhg.com.sg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 23, 2007
• First Posted: October 24, 2007
• Last Updated: May 15, 2008

Record last verified: 2008-05

Locations

SG (1)