Institut Gustave Roussy
Villejuif, 94800, France
NCT Number: NCT01226394
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).
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Notify Me18 year–70 year
All sexes
Interventional
Phase 3
Villejuif, 94800, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
A) Patients presenting with the following history:
B) Who have received standard systemic adjuvant chemotherapy (6 months of systemic chemotherapy) :
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:
E)Patients will be informed and a signed consent form will be obtained before initiating any procedure specific to the trial.
Exclusion criteria
Laparotomy + HIPEC
Time frame: 3 years
3-year disease-free survival
Time frame: 3 years
Time frame: 3 years
Time frame: 5 years
Gustave Roussy, Cancer Campus, Grand Paris
Other
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
Acronym: ProphyloCHIP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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