A Phase II, Randomized Study of Cytoreductive Surgery Combined With Niraparib Maintenance in Platinum-sensitive, Secondary Recurrent Ovarian Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 167
- 试验地点
- 5
- 主要终点
- 12-month disease non-progression rate
研究概览
简要总结
This is a Phase II, open-label, multicenter, randomized umbrella study to evaluate the efficacy of cytoreductive surgery and Niraparib maintenance in participants with platinum-sensitive secondary recurrent ovarian cancer. Cohort 1 will focus on participants without prior use of PARP inhibitor, and without prior secondary cytoreduction (SCR) when first recurrence. Cohort 2 will focus on participants with prior use of PARP inhibitor, but without prior SCR when first recurrence. Cohort 3 will focus on participants with SCR when first recurrence, but without prior use of PARP inhibitor.
详细描述
This exploratory trial is to compare the efficacy of secondary cytoreductive surgery followed by chemotherapy and Niraparib maintenance, versus chemotherapy alone followed by Niraparib maintenance in patients with platinum-sensitive secondary recurrent ovarian 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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years to ≤ 75 years
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- •Patients with platinum-sensitive, secondary relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer.
- •Front-line or second-line treatment may have included maintenance therapy (i.e. bevacizumab, PARP inhibitor)
- •Cohort 1 and Cohort 3: No prior use of PARP inhibitor.
- •Cohort 2: Prior use of PARP inhibitor.
- •Cohort 3: No prior use of PARP inhibitor.
- •Secondary cytoreductive surgery (SCR) when first recurrence
- •Cohort 1 and Cohort 2: Never received SCR
- •Cohort 2: Never received SCR
- •Cohort 3: Received SCR
- •Assessed by the experienced surgeons, complete resection of all recurrent disease is possible. Single or localized lesions identified by CT, or MRI, or positron emission tomography/computed tomography (PET/CT). PI and Co-PI reach consensus if extensive lesions or carcinomatosis.
- •It can be included if single lesion outside the peritoneal cavity can be resected.
- •No more than 3 disease lesions by central-reviewed PET/CT imaging if the participated center has never participated in any surgical trials on ovarian cancer before.
- •Patients who have given their signed and written informed consent and their consent.
排除标准
- •Patients with borderline tumors as well as non-epithelial tumors.
- •Patients for interval-debulking, or for second- or third-look surgery, or palliative surgery planned.
- •Impossible to assess the resectability. Radiological signs suggesting complete resection is impossible.
- •Patients who have received more than two previous regimen of chemotherapy (maintenance is not considered a third regimen).
- •Third relapse or more.
- •Patients with second or other malignancies who have been treated by surgery, if the treatment might interfere with the treatment of relapsed ovarian cancer or if major impact on prognosis is expected.
- •Progression during chemotherapy or recurrence within 6 months after second-line platinum-based therapy
- •Any contradiction not allowing surgery and/or chemotherapy and/or or Niraparib
- •Accompanied by hypoxia serious chronic obstructive pulmonary disease
- •Uncontrolled hypertension, cerebrovascular accident/ Stroke, myocardial infarct, unstable angina, untreated thrombosis, chronic congestive heart failure, or serious arrhythmia in need of medicine.
- •Severe hepatitis, history of liver disease, nephrotic syndrome, renal insufficiency
- •Active ulcer history, abdominal wall fistula, perforation of gastrointestinal tract, or Intra-abdominal abscess, or simultaneously apply treatment/prevent ulcers therapy.
- •Uncontrolled diabetes
- •Uncontrolled epilepsy need long-term antiepileptic treatment.
- •Any medication induced considerable risk of surgery, e.g. estimated bleeding due to oral anticoagulating agents.
- •≥3 grade anemia, neutropenia or thrombocytopenia due to chemotherapy, and lasted for more than 4 weeks
- •Patients with a known hypersensitivity to Niraparib or any of the excipients of the product.
研究组 & 干预措施
Surgery
Intervention:
Procedure: Maximum effort cytoreductive surgery combined with Niraparib maintenance Drug: Platinum-based chemotherapy and Niraparib
干预措施: Surgery (Procedure)
Surgery
Intervention:
Procedure: Maximum effort cytoreductive surgery combined with Niraparib maintenance Drug: Platinum-based chemotherapy and Niraparib
干预措施: carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin... (Drug)
Surgery
Intervention:
Procedure: Maximum effort cytoreductive surgery combined with Niraparib maintenance Drug: Platinum-based chemotherapy and Niraparib
干预措施: Niraparib (Drug)
No surgery
Intervention: Drug: Platinum-based chemotherapy and Niraparib
干预措施: carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin... (Drug)
No surgery
Intervention: Drug: Platinum-based chemotherapy and Niraparib
干预措施: Niraparib (Drug)
结局指标
主要结局
12-month disease non-progression rate
时间窗: up to 12 months after last patient randomized
12-month non-progression rate
次要结局
- 30-day post-operative complications(From the operation until after 30 days)
- Progression-free survival(Up to 24 months after last patient randomized)
- Treatment free survival(Up to 24 months after last patient randomized)
- Overall survival(Approximately up to 24 months after last patient randomized)
- Quality of life assessment(baseline; 6 and 12 months after randomization)