Status:
UNKNOWN
Patient-tailored Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Colorectal Peritoneal Metastases (OrganoHIPEC)
Lead Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Conditions:
Peritoneal Metastases From Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The objective of this clinical trial is to demonstrate that cytoreductive surgery and patient-tailored hyperthermic intra-peritoneal chemotherapy (HIPEC) will increase efficacy in controlling peritone...
Detailed Description
This single-arm, single-center, open-label trial enrolls patients with limited and surgically resectable peritoneal metastases from colorectal cancer, no distant metastases, and no contraindication to...
Eligibility Criteria
Inclusion
- diagnosis of peritoneal metastases from intestinal-type or mucinous colo-rectal adenocarcinoma, by histological/cytological confirmation.
- limited to moderate peritoneal involvement: peritoneal cancer index (PCI) ≤ 20;
- peritoneal disease potentially amenable to complete surgical cytoreduction;
- no evidence of hepatic, extra-regional nodal, or extra abdominal metastases
- World Health Organization (WHO) performance status ≤2;
- willingness to undergo preliminary laparoscopy, perioperative s-CT, and post-operative follow-up;
- signature of informed consent.
Exclusion
- active sepsis;
- impaired cardiac function (history of previous heart failure or 40% ejection fraction);
- impaired renal function (serum creatinine \>1.5 normal value or creatinine clearance \< 60 ml/min);
- impaired liver function (aspartate aminotransferase, alanine aminotransferase, bilirubin \> 1.5 normal value);
- impaired bone marrow function (leukocytes \<4000/mm3, neutrophils \<1500/mm3, platelets \<80000/mm3);
- impaired lung function (diagnosis of severe chronic obstructive pulmonary disease or 50% forced expiratory volume at one second or 40% diffusion capacity of lung for carbon monoxide adjusted for age);
- dehydropyrimidine dehydrogenase deficiency;
- pregnancy or lactation in progress;
- haemorrhagic diathesis or coagulopathy;
- any other condition or comorbidity that prevents safe administration of systemic chemotherapy (e.g. severe diarrhea, stomatitis or ulceration in the mouth or gastrointestinal tract);
- psychiatric or neurological conditions that preclude the procedures of the protocol;
- any contraindication to laparoscopy;
- known hypersensitivity to any of the chemotherapy agents used for HIPEC in the present study and/or to any of their excipients;
- history of previous malignancies treated in the last three years, excluding cutaneous spinocellular carcinoma and/or basocellular carcinoma;
- previous cytoreductive surgery and HIPEC
Key Trial Info
Start Date :
June 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 14 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06057298
Start Date
June 15 2021
End Date
June 14 2025
Last Update
October 24 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133