An interventional study of Pressurized intraperitoneal aerosol chemotherapy (PIPAC) in Peritoneal Metastases From Colorectal Cancer, sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-10-19.
Sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Not applicable, Interventional, and Treatment
The objective of this clinical trial is to demonstrate the feasibility and safety of pressurized intraperitoneal aerosol chemotherapy (PIPAC) for the prevention of peritoneal metastases after curative-intent surgery for high-risk colorectal cancer.
This single-arm, single-center, open-label trial enrolls patients after curative-intent surgery for colon adenocarcinoma (proximal to peritoneal reflection), intestinal or mucinous histological type, associated with the following clinical-pathological risk factors for the development of peritoneal metastases: a) stage pT4a, N0-2b, M0 of the Tumor Node Metastasis classification; b) stage pT4b, N0-2b, M0; and c) primary perforated tumor (any T, any N, M0). Eligible patients who will give informed consent undergo laparoscopic pressurized intraperitoneal aerosol chemotherapy (PIPAC) 4 to 8 weeks after primary surgery, followed by adjuvant systemic chemotherapy according to according to current guidelines. After the procedure, patients will be followed-up to assess occurrence of adverse events,survival, peritoneal and systemic disease relapse, and quality of life.
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano is the lead sponsor of 172 studies on the registry; 50 are open to participants now.
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presence of at least one of the following risk factors for the development of metachronous peritoneal metastases:
Exclusion Criteria:
Preliminary laparoscopic exploration of the abdominal cavity and adjuvant pressurized intraperitoneal aerosol chemotherapy (PIPAC) with oxaliplatin and concurrent intravenous infusion of 5-fluorouracil and folinic acid.
Procedure: Pressurized intraperitoneal aerosol chemotherapy (PIPAC)
Laparoscopic exploration of the abdominal cavity with dissection of adhesions and biopsies of suspect findings (if needed). PIPAC will be administered with oxaliplatin (92 mg/m2 body surface area in 150 ml dextrose solution) for 30 minutes under the following spraying conditions: cytostatic application at a rate of 30 ml/min, pressure of 1380 kilo-pascal over 30 minutes, and temperature of 22°C. One hour before the beginning of PIPAC, intravenous infusion of 5-fluorouracil (400 mg/m2) and folinic acid (20mg/m2) will be initiated. Standard protectionist procedures will be adopted to avoid contamination of operators and the environment with nebulized chemotherapy.
Feasibility of adjuvant pressurized intraperitoneal aerosol chemotherapy (PIPAC)
The adjuvant PIPAC performed in an early setting after primary surgery will be considered feasible if: * the laparoscopic procedure can be completed in 9 patients; * the postoperative stay will be three days or shorter in ≥6 patients; * the post-operative adjuvant s-CT will begin within 12 weeks of primary surgery in ≥ 9 patients.
Time frame: 12 weeks
Safety of adjuvant pressurized intraperitoneal aerosol chemotherapy (PIPAC)
The adjuvant PIPAC will be considered a well tolerated procedure if: * a maximum of one serious treatment-related complication will occur; * a maximum of one laparotomy conversion will occur; * a maximum of one hospital readmission will occur within 30 days.
Time frame: 30 days
Overall survival
Overall survival will be measured from the date of primary surgery to the date of death for any cause or, for patients still alive at the date of the last available follow-up.
Time frame: 60 months
Disease-free survival
Disease-free survival will be measured from the date of primary surgery to the date of peritoneal metastasis diagnosis, systemic metastases or death.
Time frame: 60 months
Peritoneal disease-free survival
Peritoneal disease-free survival will be measured from the date of primary surgery to the date of peritoneal metastasis diagnosis,
Time frame: 60 months
Plan to share: Yes — I confirm that we have a plan to make individual participant data (IPD) available to other researchers through publicly available database
Supporting information: Study protocol, Clinical study report
Time frame: after the completion of the study, for additional 60 months
Access criteria: upon reasonable request to the principal investigator
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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