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Randomized Trial Between Weekly and 5 Day 3 Weekly Cisplatin for Cervical Cancer
Conditions
Locally Advanced Cervical Cancer
Conditions: official terms
Uterine Cervical Neoplasms
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Cisplatin
Type: Drug
Overall Status
Not yet recruiting
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
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 21 Years
Gender: Female
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
- 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
Location
National University Hospital
Singapore, Singapore
Status: Not yet recruiting
Sponsors
National University Hospital, Singapore
Source
National University Hospital, Singapore
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page