Randomized Phase II Study of 3 vs 6 Courses of Neoadjuvant Carboplatin-paclitaxel Chemotherapy in Stage IIIC or IV Epithelial Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 129
- 试验地点
- 5
- 主要终点
- Percentage of patients who obtain a complete cytoreduction (no macroscopic residual tumor) at surgery , as a comparative outcome measure of 3 vs 6 courses of neoadjuvant chemotherapy
研究概览
简要总结
The purpose of this study is to define whether 6 courses of neoadjuvant chemotherapy can lead to a higher rate of complete cytoreductive surgery compared with 3 courses of neoadjuvant chemotherapy in patients with epithelial ovarian cancer, fallopian tube cancer or primary peritoneal 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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients ≥18 years.
- •Karnofsky Performance Scale ≥ 60%
- •Histologically confirmed epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma with the exception of mucinous, clear cell, low-grade carcinoma and carcinosarcoma histologies.
- •Documented International Federation of Gynecologic Oncology (FIGO) stage IIIC-IV oligometastatic unsuitable for complete primary cytoreductive surgery. Inoperability must be confirmed by open laparoscopy or by laparotomy.
- •Adequate bone marrow, liver and renal function to receive chemotherapy and subsequently to undergo surgery:
- •white blood cells >3,000/µL, absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL,
- •serum creatinine <1.25 x upper normal limit (UNL) or creatinine clearance ≥60 mL/min according to Cockroft-Gault formula or to local lab measurement
- •serum bilirubin <1.25 x UNL, AST(SGOT) and ALT(SGPT) <2.5 x UNL.
- •Signed informed consent obtained prior to any study-specific procedures
排除标准
- •Mucinous, clear cell, low-grade carcinoma and carcinosarcoma histologies.
- •Synchronous or previous other malignancies within 3 years prior to starting study treatment, with the exception of adequately treated non-melanomatous skin cancer or carcinoma in situ (of the cervix or breast or other sites).
- •Patients with brain metastases, seizure not controlled with standard medical therapy, or history of cerebrovascular accident (CVA, stroke) or transient ischemic attack (TIA) or subarachnoid hemorrhage within 6 months from the enrollment on this study.
- •Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol (including but not limited to impaired cardiac function or clinically significant cardiac diseases, active or uncontrolled infections, HIV-positive patients on antiretroviral therapy, uncontrolled diabetes, cirrhosis, chronic active or persistent hepatitis, impaired respiratory function requiring oxygen-dependence,serious psychiatric disorders).
- •Pregnant or breastfeeding women.
研究组 & 干预措施
Arm A: 3 courses
Patients will receive 3 courses of i.v. carboplatin AUC 5 and paclitaxel 175 mg/m2 every 3 weeks, followed by cytoreductive surgery within 6 weeks from the last cycle of chemotherapy. Alternatively, the Participating Centres can use the weekly paclitaxel schedule: carboplatin AUC 6 day 1 and paclitaxel 80 mg/m2 day 1-8-15.
干预措施: carboplatin and paclitaxel followed by surgery (Drug)
Arm B: 6 courses
Patients will receive 6 courses of i.v. carboplatin AUC 5 and paclitaxel 175 mg/m2 every 3 weeks, followed by cytoreductive surgery within 6 weeks from the last cycle of chemotherapy. Alternatively, the Participating Centres can use the weekly paclitaxel schedule: carboplatin AUC 6 day 1 and paclitaxel 80 mg/m2 day 1-8-15.
干预措施: carboplatin and paclitaxel followed by surgery (Drug)
结局指标
主要结局
Percentage of patients who obtain a complete cytoreduction (no macroscopic residual tumor) at surgery , as a comparative outcome measure of 3 vs 6 courses of neoadjuvant chemotherapy
时间窗: within 6 weeks after the last cycle of chemotherapy
The primary objective of this study is to define whether 6 courses of neoadjuvant chemotherapy can lead to a higher rate of complete cytoreductive surgery compared with 3 courses of neoadjuvant chemotherapy in patients with bulky stage IIIC or IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer
次要结局
- Rate of radiological responses(at the end of neoadjuvant chemotherapy, before surgery)
- Rate of overall survival(from date of randomization until date of death due to any cause, assessed until 10 years after the end of chemotherapy)
- Percentage of patients with grade 3-5 perioperative toxicity (according to CTCAE), as a measure of safety(within 30 days after surgery)
- Percentage of patients with pathological complete response(after surgery, up to 1 month after surgery)
- Rate of progression-free survival(from date of randomization until the date of disease progression or second cancer or death from any cause, whichever occurs first, assessed for 10 years after the end of chemotherapy)
- Health related quality of life(from baseline to safety follow-up visit (30-34 days after surgery))
- Rate of decrease of CA125 levels during NACT(from cycle 1 of chemotherapy to safety follow-up visit (30-34 days after surgery))
研究者
Claudio Zamagni MD
MD Medical Oncologist
IRCCS Azienda Ospedaliero-Universitaria di Bologna