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Trial Title:
Randomized Trial Between Weekly and 5 Day 3 Weekly Cisplatin for Cervical Cancer
NCT ID:
NCT00548821
Condition:
Locally Advanced Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Cisplatin
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cisplatin
Arm group label:
1
Arm group label:
2
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.
Criteria for eligibility:
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
Gender:
Female
Minimum age:
21 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National University Hospital
Address:
City:
Singapore
Zip:
119074
Country:
Singapore
Lead sponsor:
Agency:
National University Hospital, Singapore
Agency class:
Other
Source:
National University Hospital, Singapore
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00548821
