A Phase III Randomized Study Evaluating Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) in the Treatment of Relapse Ovarian Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- UNICANCER
- 入组人数
- 415
- 试验地点
- 52
- 主要终点
- overall survival
研究概览
简要总结
CHIPOR hypothesis is that the adjunction of platinum HIPEC in first relapsed epithelial ovarian cancer is able to improve the median Overall Survival (OS) by 12 months. In that hypothesis, with alpha risk of 5%, a power beta of 80%, during a 3 years period of inclusion and a 3 years follow-up, the number of patients to include is 404. Taking into account a 10% failure, an overall number of 444 patients is required.
详细描述
The patient received before the surgery a second line chemotherapy, platinum-based regimen with either carboplatine-paclitaxel, or carboplatine-caelyx. At the end of the six courses IV chemotherapy, if the disease is still responding and if a complete cytoreductive surgery seems possible, the patient is included after signed informed consent and will be operated 5 to 8 weeks after the last second-line chemotherapy cycle.
So, during the surgery the patient will be randomized if the complete cytoreductive surgery is really done and will then receive:
- either treatment A = maximal cytoreductive surgery without HIPEC
- or treatment B = maximal cytoreductive surgery with HIPEC
The HIPEC will be done at the end of the surgery. At the end of cytoreductive surgery, tumor residual disease must be null or very limited (Sugarbaker completeness cytoreduction: CC0 (no residual)-CC1 (residual < 0.25cm).
Two methods will be used for the HIPEC: Open or closed abdomen, depends on the site practice. Each site will use the same method during the study for all included patients.
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
- •Patient age ≥ 18 years
- •Performance Status WHO < 2
- •Initially treated for Epithelial Ovarian Carcinoma
- •Patient with only peritoneal relapse occurred at least 6 month from the initial treatment, resectable without distant metastasis (with the exception of communicating pleura effusion, sensitive to platine-based second line chemotherapy and resectable lymph-nodes in the groin or retro peritoneal)
- •Platinum based second-line chemotherapy before surgery with either carboplatine-paclitaxel, or carboplatine-caelyx
- •Complete cytoreductive surgery
- •The surgery has to be planned 5 to 8 weeks from the last 2nd of chemotherapy
- •No hepatic failure, bilirubin ≤ 1,5 time the Normal limit, ASAT and ALAT ≤ 3 time the Upper Normal Limit
- •No Renal insufficiency (serum creatinine < 1,5 time the normal limit, creatinine clearance > 80 mL/min). calculated with MDRD method
- •Hematology function: PNN ≥ 1,5x10⁹/L, platelets ≥ 100x10⁹/L
- •No contraindication to general anaesthesia for heavy surgery
- •Patients having read, signed and dated Informed consent before any study procedure
- •Childbearing patients have to take appropriate contraceptive methods during the treatment and until 6 months after the treatment
排除标准
- •Patient age <18 years
- •Previous cancer in the last 5 years (except cutaneous baso-cellular epithelioma or uterine peripheral epithelioma)
- •Hypersensitivity to Platinum compound
- •Distant metastasis
- •Use of anti-angiogenic treatment
- •Patient with other concurrent severe life threatening disease
- •The need to perform more than two segmental digestive resections during the CRS +/- HIPEC surgery
- •Any progressive disease during the IV systemic second-line chemotherapy (platine-based)
- •Incomplete cytoreductive surgery with macroscopical residual disease (Sugarbaker > CC1)
- •Early relapse: less than 6 mois after the end of the first treatment
- •Ovarian tumor other than Epithelioma Ovarian Cancer
- •Uncontrolled infection
- •Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •Clinically significant cardiovascular disease contraindicating the hyper hydratation, which is necessary for HIPEC
- •Patient already treated with HIPEC for the ovarian cancer
- •Individual deprived of liberty or placed under the authority of a tutor
研究组 & 干预措施
maximal cytoreductive surgery with HIPEC
The participant will have a regular cytoreductive surgery, then the adjunction of HIPEC: hyperthermic cisplatin will be used at 75mg/m²
干预措施: HIPEC (Drug)
maximal cytoreductive surgery without HIPEC
The participant will have a regular cytoreductive surgery without the adjunction of HIPEC.
干预措施: Maximal cytoreductive surgery (Procedure)
maximal cytoreductive surgery with HIPEC
The participant will have a regular cytoreductive surgery, then the adjunction of HIPEC: hyperthermic cisplatin will be used at 75mg/m²
干预措施: Maximal cytoreductive surgery (Procedure)
结局指标
主要结局
overall survival
时间窗: from randomization to death (up to 4 years)
Follow-up of 4 years.
次要结局
- relapse free survival(from randomization to relapse (up to 4 years))