Trial Comparing Simple Follow-up to Exploratory Laparotomy Plus "in Principle" (Hyperthermic Intraperitoneal Chemotherapy) HIPEC in Colorectal Patients (ProphyloCHIP)
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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).
Condition or disease
Colorectal Cancer With a Resected Minimal Synchronous PCOvarian MetastasesTumour Rupture in the Abdominal Cavity
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
Study Start Date :
Estimated Primary Completion Date :
Estimated Study Completion Date :
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Ages Eligible for Study:
18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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,
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Wounds and Injuries
Body Temperature Changes
Signs and Symptoms
Carcinoma, Signet Ring Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Cystic, Mucinous, and Serous