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
  Purpose

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.


Condition Intervention Phase
Locally Advanced Cervical Cancer
Drug: Cisplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Randomized Trial Between 5 Day 3 Weekly and Weekly Cisplatin Based Chemotherapy for Patients With Locally Advanced Cervical Cancer

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

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

Arms Assigned Interventions
Experimental: 2
ARM 2: Weekly cisplatin 40mg/m2, concurrent with radiotherapy.
Drug: Cisplatin
Experimental: 1
ARM 1: 5-day 3 weekly cisplatin 20mg/m2 for 5 days, concurrent with radiotherapy
Drug: Cisplatin

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548821

Contacts
Contact: Johann Tang 677204870 Johann_Tang@mail.nhg.com.sg

Locations
Singapore
National University Hospital Not yet recruiting
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Johann Tang NUH
  More Information

No publications provided

Responsible Party: Dr Johann Tang, National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT00548821     History of Changes
Other Study ID Numbers: Cervix Cancer Research
Study First Received: October 23, 2007
Last Updated: May 13, 2008
Health Authority: Singapore: Health Sciences Authority

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014