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
Overview
- Phase
- Phase 3
- Intervention
- Radiation therapy
- Conditions
- Cervical Cancer
- Sponsor
- Asan Medical Center
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Response rate
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief Summary
Concurrent chemoradiation therapy with weekly cisplatin is the current standard treatment for patients with locally advanced cervical cancer. However, weekly cisplatin is related to renal toxicity and not convenient regimen. Recently, carboplatin has proved to be a good radiosensitizer and less renal toxicity. Weekly carboplatin is more convenient regimen for both patients and physicians. Weekly carboplatin may have similar efficacy with weekly cisplatin and may have more favorable toxicity profile. Therefore, the investigators aimed to evaluate the efficacy and safety of concurrent chemoradiation with weekly carboplatin in patients with locally advanced cervical cancer.
Investigators
Joo-Hyun Nam
Professor
Asan Medical Center
Eligibility Criteria
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
Arms & Interventions
CCRT weekly carboplatin
Concurrent chemoradiation therapy with weekly carboplatin
Intervention: Radiation therapy
CCRT weekly carboplatin
Concurrent chemoradiation therapy with weekly carboplatin
Intervention: Carboplatin
CCRT weekly cisplatin
Concurrent chemoradiation therapy with weekly cisplatin
Intervention: Radiation therapy
CCRT weekly cisplatin
Concurrent chemoradiation therapy with weekly cisplatin
Intervention: Cisplatin
Outcomes
Primary Outcomes
Response rate
Time Frame: 3 months after completion of study treatment
Secondary Outcomes
- Number of patients with adverse events as a measure of safety and tolerability(Before each chemotherapy, an average of 1 week)
- Disease-free survival(2 years after completion of study treatment)
- Overall survival(2 years after completion of study treatment)
- Quality of life(3 months after completion of study treatment)