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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
RECRUITINGFeasibility 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
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