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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT06091683
Study type Interventional
Source Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Contact Dario Baratti, MD
Phone +390223901
Email dario.baratti@istitutotumori.mi.it
Status Recruiting
Phase N/A
Start date April 30, 2021
Completion date December 31, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT06057298 - Patient-tailored Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Colorectal Peritoneal Metastases (OrganoHIPEC) N/A
Terminated NCT03398512 - HIPEC and Systemic Chemotherapy in Unresectable Peritoneal Metastases From Colorectal Cancer N/A