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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by National University Hospital, Singapore.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00548821
First received: October 23, 2007
Last updated: May 13, 2008
Last verified: May 2008

October 23, 2007
May 13, 2008
Not Provided
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00548821 on ClinicalTrials.gov Archive Site
The secondary aims are to compare quality of life assessment of patients and their carers as well as toxicity profiles both acute and late.
Same as current
Not Provided
Not Provided
 
Randomized Trial Between Weekly and 5 Day 3 Weekly Cisplatin for Cervical Cancer
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Locally Advanced Cervical Cancer
Drug: Cisplatin
  • Experimental: 2
    ARM 2: Weekly cisplatin 40mg/m2, concurrent with radiotherapy.
    Intervention: Drug: Cisplatin
  • Experimental: 1
    ARM 1: 5-day 3 weekly cisplatin 20mg/m2 for 5 days, concurrent with radiotherapy
    Intervention: Drug: Cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
Not Provided
Not Provided
Not Provided

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
Female
21 Years and older
No
Contact: Johann Tang 677204870 Johann_Tang@mail.nhg.com.sg
Singapore
 
NCT00548821
Cervix Cancer Research
Yes
Dr Johann Tang, National University Hospital, Singapore
National University Hospital, Singapore
Not Provided
Principal Investigator: Johann Tang NUH
National University Hospital, Singapore
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP