Prophylactic Surgery Plus Hyperthermic Intraperitoneal Chemotherapy (HIPEC CO2) Versus Standard Surgery in Colorectal Carcinoma at High Risk Peritoneal Carcinomatosis. Short and Long-term Outcomes. CHECK STUDY
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 330
- 试验地点
- 16
- 主要终点
- Local recurrence free survival (LRFS)
研究概览
简要总结
This is a phase III randomized, multicenter study with two different arm:
- experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin
- comparator: standard surgery Adjuvant treatment after surgery is mandatory except for documented cases of non-eligibility.
Patient will be randomized in a 1:1 ratio. Randomization will be done during surgery if the total resection of tumour will be reached and will use a stratification procedure based on center
详细描述
This is a phase III randomized, multicenter study with two different arm:
- experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin
- comparator: standard surgery Adjuvant treatment after surgery is mandatory except for documented cases of non-eligibility.
Patient will be randomized in a 1:1 ratio. Randomization will be done during surgery if the total resection of tumour will be reached and will use a stratification procedure based on center
The HIPEC CO2 regimen will be as reported below:
mitomycin: (total dose of 35 mg/mq, physiologic solution 0.9%) administrated 50% at time 0 from start of HIPEC CO2 treatment (17.5 mg/mq), 25% (8.8 mg/mq) after 30 minutes and the last dose 25% after 60 minutes. Recommended temperature for HIPEC treatment is 41-42 °C for 90 minutes.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically documented colorectal adenocarcinoma eligible for R0,
- •Presurgical or intraoperative stage T4a or T4b primary tumour (TNM 8 th)
- •Urgent presentation: perforation without purulent generalized peritonitis or fecal peritonitis
- •Peritumoral minimal peritoneal carcinomatosis: limited peritoneal disease in close proximity to the primary tumour, that may be removed en bloc
- •Ovarian metastases (Krukenberg tumor)
- •Age ≥ 18 and ≤75 years
- •Written informed consent
排除标准
- •Distant metastatic disease (even if limited and completely resected)
- •History of tumour diagnosed in the 3 years before entering the study, except for topical and healed pathologies that do not need further treatment (e.g. non-melanoma skin carcinomas, superficial bladder carcinomas or in situ carcinoma of the breast or cervix).
- •Psychological, family or social conditions which may negatively affect the treatment and follow-up protocol.
- •Poor general conditions (ECOG > 2).
- •Impaired cardiac function (history of congestive heart failure or FE <40%). Clinically significant cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrolment), myocardial infarction (<6 months prior to enrolment), unstable angina, congestive heart failure (New York Heart Association Classification Class > II or serious uncontrolled cardiac Arythmia requiring medication
- •Impaired renal function (creatinine> 1.5 upper limit of normal or creatinine clearance <60 mL / min)
- •Impaired hepatic function (AST, ALT >2.5 upper limit of normal, bilirubin> 1.5 upper limit of normal)
- •Impaired hematopoietic function (leucocytes <4000 / mm3, neutrophils <1500 / mm3, platelets <100000 / mm3)
- •Impaired pulmonary function (presence of COPD or other pulmonary restrictive conditions with FEV1 <50% or DLCO <40% of normal age value).
- •History or presence of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of HIPEC or chemotherapy or patient at high risk from treatment complications.
- •Chronic inflammatory bowel disease
- •Patients with acute bowel obstruction
- •Refusal to join the study
研究组 & 干预措施
Experimental
ARM A: Prophylactic surgery plus HIPEC CO2 performed with mitomycin
干预措施: HIPEC CO2 surgery (Procedure)
Experimental
ARM A: Prophylactic surgery plus HIPEC CO2 performed with mitomycin
干预措施: Mitomycin (Drug)
Comparator
ARM B: Standard surgey without HIPEC CO2 The arm B is with standard surgery without HIPEC CO2
干预措施: Standard surgery (Procedure)
结局指标
主要结局
Local recurrence free survival (LRFS)
时间窗: This outcome measure will be assess approximately 3 years after the last patient enrolled
The primary efficacy endpoint is LRFS defined as the time from randomization to the date of first local relapse, peritoneal carcinomatosis or death for any cause, whichever comes first.
次要结局
- Overall Survival (OS)(This outcome measure will be assessed approximately 3 years after the last patient enrolled)
- duration of surgery(This outcome measure will be assessed approximately 3 years after the last patient enrolled)
- number of patients performing the adjuvant chemotherapy.(This outcome measure will be assessed approximately 3 years after the last patient enrolled)
- mortality at 30 and 90 days from surgery(This outcome measure will be assessed approximately 3 years after the last patient enrolled)
- Disease Free Survival (DFS)(This outcome measure will be assess approximately 3 years after the last patient enrolled)
- number of post-surgery complication(This outcome measure will be assessed approximately 3 years after the last patient enrolled)
- length of hospitalization(This outcome measure will be assessed approximately 3 years after the last patient enrolled)
- morbidity(This outcome measure will be assessed approximately 3 years after the last patient enrolled)