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
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
CCRT weekly carboplatin
Concurrent chemoradiation therapy with weekly carboplatin
干预措施: Radiation therapy (Radiation)
CCRT weekly carboplatin
Concurrent chemoradiation therapy with weekly carboplatin
干预措施: Carboplatin (Drug)
CCRT weekly cisplatin
Concurrent chemoradiation therapy with weekly cisplatin
干预措施: Radiation therapy (Radiation)
CCRT weekly cisplatin
Concurrent chemoradiation therapy with weekly cisplatin
干预措施: Cisplatin (Drug)
结局指标
主要结局
Response rate
时间窗: 3 months after completion of study treatment
次要结局
- 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)
研究者
Joo-Hyun Nam
Professor
Asan Medical Center