Viewing Study NCT06057298



Ignite Creation Date: 2024-05-06 @ 7:33 PM
Last Modification Date: 2024-10-26 @ 3:09 PM
Study NCT ID: NCT06057298
Status: RECRUITING
Last Update Posted: 2023-10-24
First Post: 2023-09-21

Brief Title: Patient-tailored Hyperthermic Intraperitoneal Chemotherapy HIPEC for Colorectal Peritoneal Metastases OrganoHIPEC
Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori Milano
Organization: Fondazione IRCCS Istituto Nazionale dei Tumori Milano

Study Overview

Official Title: Organoids From Colorectal Peritoneal Metastases to Improve Cytoreductive Surgery and Patient-tailored Hyperthermic Intraperitoneal Chemotherapy HIPEC
Status: RECRUITING
Status Verified Date: 2023-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: OrganoHIPEC
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 peritoneal disease Tridimensional cell cultures organoids derived from colorectal cancer peritoneal metastases are used to select the most active drugs in an in vitro HIPEC model on individual-patient level based on the hypothesis that resistance to drugs routinely used for intraperitoneal delivery can explain peritoneal relapse after combined treatment depending on the individual tumor biology
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 major surgery After signature of informed consent patients undergo a preliminary laparoscopy to confirm diagnosis of peritoneal metastases stage the disease and obtain representative samples of peritoneal metastases The investigators will use patient-derived organoids to select tailored hyperthermic intra-peritoneal chemotherapy HIPEC regimens in an in vitro model HIPEC A set of candidate drugs suitable for intraperitoneal administration are tested on tumor-derived organoids under the same conditions as in the clinical practice same drug combinations concentration exposure time temperature Different concentrations are tested to generate reproducible dose-response curves Patients receive 3-6 month preoperative systemic chemotherapy with targeted agents according to current guidelines Those not experiencing disease progression during preoperative systemic chemotherapy will have cytoreductive surgery and HIPEC with drugs selected on the organoid-based preclinical model Patients will undergo postoperative follow-up

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
RF-2019-12370456 OTHER_GRANT Italian Health Minister Ricerca Finalizzata None