NCT01226394已完成3 期
Multicentric Phase III Trial Comparing Simple Follow-up to Exploratory Laparotomy Plus "in Principle" HIPEC (Hyperthermic Intraperitoneal Chemotherapy) in Colorectal Patients Initially Treated With Surgery and Adjuvant Chemotherapy Who Have a High Risk of Developing Colorectal Peritoneal Carcinomatosis
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- To increase the 3-year disease-free survival
研究概览
简要总结
Multicentric randomised trial. Patients with a high risk of developing colorectal Peritoneal Carcinomatosis (PC) after resection of their primary will be informed, will sign the consent and will be pre-registered. All patients will receive the current standard adjuvant treatment : 6 months of systemic chemotherapy (currently the Folfox-4 regimen which could be modified if the standard is modified). Then a work-up is done to exclude recurrence. The likelihood of a recurrence is low but if this occurs, the patient will not be randomised and will be treated with the best known treatment. If the work-up is negative, patients will be randomised to surveillance alone (control group) or exploratory laparotomy + HIPEC (experimental group).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A) Patients presenting with the following history:
- •Histologically-proven colorectal adenocarcinoma
- •Presenting at the time of resection of the primary with one of the following 4 criteria (criteria indicating a high risk of developing PC) :
- •Minimal PC, resected at the same time as the primary
- •Ovarian metastases
- •Rupture of the primary tumour inside the peritoneal cavity,
- •Iatrogenic rupture of the primary tumour during surgery
- •B) Who have received standard systemic adjuvant chemotherapy (6 months of systemic chemotherapy) :
- •Chemotherapy with the Folfox 4 regimen (the current standard treatment ; it can be modified in the future in the two groups, if the standard is modified…).
- •Given on an intent-to-treat basis (it can be stopped prematurely for miscellaneous reasons…);
- •C) Patients who do not present any sign of tumour recurrence at the end of these 6 months of chemotherapy.
- •D) Patients with the following general characteristics:
- •Age between 18 and 70 years,
- •Performance Status WHO < 2, life expectancy > 12 weeks,
- •Haematological parameters : Polynuclear neutrophils ³ 1.5x109/L, platelets ³ 100x109/L,
- •Liver function : Total Bilirubin £ 1.5 x ULN, AST (SGOT) et ALT (SGPT) £ 3 x ULN, alkaline phosphatases £ 3 x ULN,
- •Renal function : Plasma creatinine £ 1,25 x ULN,
- •Operable patients,
- •Grade £ 2 peripheral neuropathy (CTC AE v3.0 annex 7)
- •Patients entitled to French National Health Insurance coverage.
- •E)Patients will be informed and a signed consent form will be obtained before initiating any procedure specific to the trial.
排除标准
- •Cancers of non colorectal origin, particularly, appendiceal cancers are excluded
- •Patients presenting with a detectable recurrent tumour
- •Grade ≥ 3 Peripheral neuropathy
- •History of cancer (excepted cutaneous basocellullar cancer or in situ carcinoma of the uterine cervix) with a recurrence during the 5 previous years
- •Patients already included in another trial concerning first-line treatment 6) Pregnant women or likely to be pregnant
- •7) Persons under guardianship 8) Follow-up impossible for geographic, social or psychological reasons
研究组 & 干预措施
surveillance
No Intervention
laparotomy plus HIPEC.
Experimental
干预措施: laparotomy plus HIPEC (Procedure)
结局指标
主要结局
To increase the 3-year disease-free survival
时间窗: 3 years
3-year disease-free survival
次要结局
- Peritoneal disease-free survival(3 years)
- 3 year overall survival(3 years)
- 5 year overall survival(5 years)
研究者
研究点 (1)
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