A Multicenter, Prospective, Randomized Trial Comparing Paclitaxel and Carboplatin or Bleomycin, Etoposide and Cisplatin in the Treatment of Malignant Ovarian Germ Cell Tumors
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
Investigators will conduct the trial to determine whether paclitaxel and cisplatin (PT) has the same curative effects and less adverse effects than bleomycin, etoposide and cisplatin(BEP) among newly diagnosed malignant ovarian germ cell tumor patients after surgery.
详细描述
PRIMARY OBJECTIVES:
To assess the activity of paclitaxel and carboplatin with respect to progression free survival (using bleomycin, etoposide, and cisplatin [BEP] as a reference) for newly diagnosed malignant ovarian germ cell tumors.
SECONDARY OBJECTIVES:
- To estimate the toxicity of paclitaxel and carboplatin, and bleomycin, etoposide, and cisplatin in this patient population.
- To estimate overall survival for paclitaxel and carboplatin relative to that of BEP.
- To evaluate response rate in the subset of patients with measurable disease. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
ARM 1: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
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
- None
入排标准
- 年龄范围
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age≤65 years; female, Chinese women;
- •Histologically confirmed ovarian stromal tumor, including the following cell types:
- •Granulosa cell tumor
- •Granulosa cell-theca cell tumor
- •Sertoli-Leydig cell tumor (androblastoma)
- •Steroid (lipid) cell tumor
- •Gynandroblastoma
- •Unclassified sex cord-stromal tumor
- •Sex cord tumor with annular tubules
- •Newly diagnosed, stage IIA-IVB disease;
- •Has undergone initial surgery (for diagnosis, staging, or cytoreduction) within the past 8 weeks.
- •May or may not have measurable residual disease.
- •Laboratory tests: WBC≥4×10(9)/L, NEU≥2×10(9)/L, PLT≥80×10(9)/L, serum bilirubin≤ 1.5 times the upper limit of normal, transaminase≤ 1.5 times the upper limit of normal, BUN, Cr≤ normal
- •Performance status: Karnofsky score≥60;
- •Provide written informed consent.
排除标准
- •With severe or uncontrolled internal disease, unable to receive surgery and/or unsuitable for chemotherapy;
- •History of organ transplantation, immune diseases;
- •History of serious mental illness, a history of brain dysfunction;
- •Drug abuse or a history of drug abuse;
- •Suffering from other malignancies;
- •Concurrently participating in other clinical trials
- •Unable or unwilling to sign informed consents;
- •Unable or unwilling to abide by protocol.
研究组 & 干预措施
PT (Arm 1)
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Paclitaxel (Drug)
PT (Arm 1)
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Carboplatin (Drug)
BEP (Arm 2)
Patients receive bleomycin IM daily for days 1-3, etoposide IV daily for days 1-5, cisplatin IV for days 1-5. Treatment repeats every 21 days for 3 or 4* courses in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients who have good risk will have 3 courses and those who have poor risks will have 4 courses.
干预措施: Bleomycin (Drug)
BEP (Arm 2)
Patients receive bleomycin IM daily for days 1-3, etoposide IV daily for days 1-5, cisplatin IV for days 1-5. Treatment repeats every 21 days for 3 or 4* courses in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients who have good risk will have 3 courses and those who have poor risks will have 4 courses.
干预措施: Etoposide (Drug)
BEP (Arm 2)
Patients receive bleomycin IM daily for days 1-3, etoposide IV daily for days 1-5, cisplatin IV for days 1-5. Treatment repeats every 21 days for 3 or 4* courses in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients who have good risk will have 3 courses and those who have poor risks will have 4 courses.
干预措施: Cisplatin (Drug)
结局指标
主要结局
Progression-free survival
时间窗: Date of randomization, and death due to any cause, assessed up to 5 years
PFS was definite as the time from randomization to disease recurrence (including death from recurrence if it was the first manifestation of recurrence), death without recurrence.
次要结局
- Tumor response rate(Up to 5 years)
- Overall survival(Up to 5 years)
- Chemotherapy related adverse effects in two arms(Up to 5 years)
研究者
Beihua Kong
MD. PhD.
Shandong University