NCT03917173招募中不适用
Prophylactic Surgery Plus Hyperthermic Intraperitoneal Chemotherapy (HIPEC CO2) Versus Standard Surgery in Gastric Carcinoma at High Risk of Developing Peritoneal Carcinomatosis. Short and Long-term Outcomes Evaluation.A Collaborative Randomized Controlled Trial of: ACOI, FONDAZIONE AIOM, SIC, SICE, SICO. GOETH STUDY
Mario Negri Institute for Pharmacological Research13 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2020年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 13
- 主要终点
- Disease free survival
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 and cisplatin
- comparator: standard surgery
Adjuvant treatment after surgery is mandatory except for documented cases of non-eligibility in both arms.
Patient will be randomized in a 1:1 ratio. Randomization will be performed during surgery if the total resection of tumor will be reached according to center and neoadjuvant chemotherapy as stratification variables.
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 and cisplatin
- 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 performed during surgery if the total resection of tumor will be reached according to center and neoadjuvant chemotherapy as stratification variables.
The primary objective of the study is to compare the efficacy of prophylactic surgery (radical gastric resection, appendectomy, round ligament of the liver resection and bilateral adnexectomy) plus HIPEC CO2 versus standard surgery in terms of disease free survival (DFS).
Patients affected by gastric carcinoma at high risk of developing peritoneal carcinomatosis will be randomized in this study.
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 gastric carcinoma (diffuse/intestinal histotype) eligibile for R
- •Presurgical or intraoperative stage T3-T4 N0-N+ primary tumour (TNM 8 th).
- •Urgent presentation: perforation without purulent generalized peritonitis
- •Positive cytology of peritoneal fluid (if previously obtained)
- •Age ≥ 18 years and ≤75 years.
- •Written informed consent.
排除标准
- •Gastroesophageal Junction (GEJ) cancer
- •Distant metastatic disease (even if limited and completely resected)
- •Peritoneal carcinomatosis
- •History of tumor 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), unstable angina, congestive heart failure (New York Heart Association Classification Class > II) or serious uncontrolled cardiac Arrhythmia 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 / mm 3, 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 disease, 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.
- •Krukenberg tumor
- •Refusal to join the study.
结局指标
主要结局
Disease free survival
时间窗: This outcome measure will be assessed approximately 3 years after the last patient enrolled
The primary efficacy endpoint is DFS defined as the time from randomization to the date of first local relapse or distant relapse or peritoneal carcinomatosis or death for any cause, whichever comes first.
次要结局
- Overall Survival(This outcome measure will be assessed approximately 3 years after the last patient enrolled, at the same time points of the Primary Endpoint)
- Local recurrence free survival(This outcome measure will be assessed approximately 3 years after the last patient enrolled, at the same time points of the Primary Endpoint)
- morbidity evaluated during and after surgery(This outcome measure will be assessed approximately 3 years after the last patient enrolled)
- post-surgery complication(This outcome measure will be assessed approximately 3 years after the last patient enrolled)
- patients performing the adjuvant chemotherapy.(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)
- length of hospitalization(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 at 30 and 90 days from surgery)
研究者
研究点 (13)
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