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
Recruitment status was Not yet recruiting
Sponsor:
National University Hospital, Singapore
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
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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
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 May 22, 2013