Comparison of Concurrent Chemoradiation Therapy With Weekly Cisplatin and Concurrent Chemoradiation Therapy With Weekly Carboplatin in Locally Advanced Cervical Cancer: Phase III Multicenter Prospective Randomized Controlled Trial
Phase 3
20 Years
75 Years
20 Years
75 Years
Open (Enrolling)
Female
Cervical Cancer
Female
Cervical Cancer
Trial Information
Comparison of Concurrent Chemoradiation Therapy With Weekly Cisplatin and Concurrent Chemoradiation Therapy With Weekly Carboplatin in Locally Advanced Cervical Cancer: Phase III Multicenter Prospective Randomized Controlled Trial
Inclusion Criteria:
- Previously untreated, histologically confirmed cervical cancer
- One of following histologic types Squamous carcinoma, adenocarcinoma, adenosquamous
carcinoma
- Age: 20-75 years
- GOG performance status: 0-2
- Adequate organ function Bone marrow: WBC ≥ 3,000/mm3, ANC ≥ 1,500/mm3, Platelet ≥
100X103/mm3, Hb ≥ 10.0 g/dl Kidney: Creatinine < 1.25 × UNL, Liver : AST, ALT < 3 ×
UNL, T- bilirubin < 1.5 mg/ mm3
- Contraception during study treatment
- Informed consent
Exclusion Criteria:
- Previous chemotherapy or pelvic radiation therapy
- Hormone therapy within 4 weeks
- Concomitant malignancy within 5 years except cured basal cell carcinoma of skin
- Uncontrolled medical disease
- Pregnant or lactating woman
- Etc.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
Response rate
Outcome Time Frame:
3 months after completion of study treatment
Safety Issue:
No
Authority:
Korea: Institutional Review Board
Study ID:
CCRTCICA-CXCA
NCT ID:
NCT01461772
Start Date:
December 2009
Completion Date:
November 2015
Related Keywords:
- Cervical Cancer
- Uterine Cervical Neoplasms
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