Locally Advanced Cervical Cancer
Conditions
Brief 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.
Interventions
DRUGCisplatin
Sponsors
National University Hospital, Singapore
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| The secondary aims are to compare quality of life assessment of patients and their carers as well as toxicity profiles both acute and late. | — |
Countries
Singapore
Contacts
Primary ContactJohann Tang
Outcome results
None listed