A Prospective, Multicenter, Randomized Phase II Trial on Optimal Timing of Surgery Combined with Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 9
- 主要终点
- 3-year overall survival
研究概览
简要总结
Optimal Timing of Surgery combined with Maintenance Therapy in the Front-line Treatment of Advanced Ovarian Cancer
详细描述
The purpose of this trial is to answer the fundamental question 'The Optimal Timing of Surgery' combined with Bevacizumab or Poly-adenosine Ribose Phosphate Inhbitors (PARPi), in the circumstance of primarily diagnosed advanced epithelial ovarian cancer, fallopian tube cancer and primary peritoneal carcinoma.
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
- •Females aged ≥ 18 years.
- •Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma
- •Low, Middle tumor burden and high tumor burden with cPCI score ≤ 12 based on pre-operative CT or PET/CT examination
- •Complete cytoreduction can be achieved based on CT or PET/CT examination
- •Patients must agree to undergo BRCA (breast cancer gene) and HRD (homologous recombination deficiency) testing
- •Performance status (ECOG 0-2)
- •Adequate bone marrow, renal and hepatic function to receive chemotherapy and subsequent 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.
- •Comply with the study protocol and follow-up.
- •Patients who have given their written informed consent.
排除标准
- •Non-epithelial ovarian malignancies and borderline tumors
- •Low grade ovarian cancer
- •Mucinous ovarian cancer
- •Complete cytoreduction cannot be achieved according to preoperative evaluation, including pulmonary and hepatic parenchymal metastases, unresectable extensive pleural metastases, multiple thoracic lymph nodes metastases, brain or bone metastases
- •Patient has a known hypersensitivity to the components of olaparib/bevacizumab or its excipients
- •Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ, thyroid carcinoma, or breast carcinoma (without any signs of relapse or activity, early-stage).
- •Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise adherence to the protocol.
- •Other conditions, such as religious, psychological, and other factors, that could interfere with the provision of informed consent, compliance to study procedures, or follow-up.
研究组 & 干预措施
Upfront cytoreductive surgery with maintenance therapy
Primary debulking surgery with a maximal cytoreduction of complete gross resection within 3 weeks after biopsy, followed by at least 6 cycles of adjuvant chemotherapy and maintenance therapy for patients with CR/PR after platinum-based therapy (patients with or without BRCA mutation will be maintained by PARPi or Bevacizumab respectively ).
干预措施: Primary debulking surgery (Procedure)
Upfront cytoreductive surgery with maintenance therapy
Primary debulking surgery with a maximal cytoreduction of complete gross resection within 3 weeks after biopsy, followed by at least 6 cycles of adjuvant chemotherapy and maintenance therapy for patients with CR/PR after platinum-based therapy (patients with or without BRCA mutation will be maintained by PARPi or Bevacizumab respectively ).
干预措施: PARP inhibitor (Drug)
Upfront cytoreductive surgery with maintenance therapy
Primary debulking surgery with a maximal cytoreduction of complete gross resection within 3 weeks after biopsy, followed by at least 6 cycles of adjuvant chemotherapy and maintenance therapy for patients with CR/PR after platinum-based therapy (patients with or without BRCA mutation will be maintained by PARPi or Bevacizumab respectively ).
干预措施: Bevacizumab (Drug)
Neoadjuvant chemotherapy with maintenance therapy
Neoadjuvant chemotherapy with 3 cycles of chemotherapy, then followed by interval debulking surgery. The maximal time interval between course 3 chemotherapy and IDS is 6 weeks. And then 3 cycles of adjuvant chemotherapy and maintenance therapy for patients with CR/PR after platinum-based therapy (patients with or without BRCA mutation will be maintained by PARPi or Bevacizumab respectively ).
干预措施: Neoadjuvant chemotherapy (Procedure)
Neoadjuvant chemotherapy with maintenance therapy
Neoadjuvant chemotherapy with 3 cycles of chemotherapy, then followed by interval debulking surgery. The maximal time interval between course 3 chemotherapy and IDS is 6 weeks. And then 3 cycles of adjuvant chemotherapy and maintenance therapy for patients with CR/PR after platinum-based therapy (patients with or without BRCA mutation will be maintained by PARPi or Bevacizumab respectively ).
干预措施: PARP inhibitor (Drug)
Neoadjuvant chemotherapy with maintenance therapy
Neoadjuvant chemotherapy with 3 cycles of chemotherapy, then followed by interval debulking surgery. The maximal time interval between course 3 chemotherapy and IDS is 6 weeks. And then 3 cycles of adjuvant chemotherapy and maintenance therapy for patients with CR/PR after platinum-based therapy (patients with or without BRCA mutation will be maintained by PARPi or Bevacizumab respectively ).
干预措施: Bevacizumab (Drug)
结局指标
主要结局
3-year overall survival
时间窗: Participants will be followed for at least 3 years after randomization
The proportion of patients alive at 3 years after entry into the study
次要结局
- Accumulated treatment-free survival(Participants will be followed for at least 3 years or death after randomization)
- Overall survival(Participants will be followed for at least 3 years after randomization)
- Progression-free survival(Participants will be followed for at least 3 years after randomization)
- Quality of life assessments(Participants will be followed for at least 3 years after randomization)
- TFST(Participants will be followed for at least 3 years or death after randomization)
- Post-operative complications(Participants will be followed up to 3 months after randomization)
- TSST(Participants will be followed for at least 3 years or death after randomization)
- The pattern of the first relapse(Participants will be followed for at least 3 years or death after randomization)