Randomized Trial Between Weekly and 5 Day 3 Weekly Cisplatin for Cervical Cancer
NCT ID: NCT00548821
Last Updated: 2008-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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2
ARM 2: Weekly cisplatin 40mg/m2, concurrent with radiotherapy.
Cisplatin
1
ARM 1: 5-day 3 weekly cisplatin 20mg/m2 for 5 days, concurrent with radiotherapy
Cisplatin
Interventions
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Cisplatin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
FEMALE
No
Sponsors
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National University Hospital, Singapore
OTHER
Responsible Party
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National University Hospital, Singapore
Principal Investigators
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Johann Tang
Role: PRINCIPAL_INVESTIGATOR
NUH
Locations
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National University Hospital
Singapore, , Singapore
Countries
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Central Contacts
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Other Identifiers
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Cervix Cancer Research
Identifier Type: -
Identifier Source: org_study_id
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