Adjuvant Pressurized Intraperitoneal Aerosol Chemotherapy to Prevent Colorectal Peritoneal Metastases (ProphyPIPAC)

NCT06091683 | Unknown

• 4 other identifiers: INT 0068/202020-000604-11BRI D/17/1DBSC 2020-000604-11_ID_18605
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peritoneal Metastases From Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  30 days

Secondary Outcomes (3)

• Overall survival

  60 months

• Disease-free survival

  60 months

• Peritoneal disease-free survival

  60 months

Study Arms (1)

Adjuvant pressurized intraperitoneal aerosol chemotherapy (PIPAC)

EXPERIMENTAL

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)

Interventions

Pressurized intraperitoneal aerosol chemotherapy (PIPAC) PROCEDURE

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.

Adjuvant pressurized intraperitoneal aerosol chemotherapy (PIPAC)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathological diagnosis of intestinal type, mucinous or signet ring cell adenocarcinoma of the colon (with upper limit of the tumor above peritoneal reflection);
• curative (microscopically complete) surgery performed by laparotomy or laparoscopy;
• presence of at least one of the following risk factors for the development of metachronous peritoneal metastases:
• perforated primary tumor (any T, N0-2b, M0);
• primary tumor infiltrating the visceral peritoneum (pT4a, N0-2b, M0), or directly invading adjacent organs (pT4b, N0-2b, M0);
• age \> 18;
• performance status 2 according to the World Health Organization score;
• willingness to start adjuvant systemic chemotherapy and post-operative follow-up;
• Signing of informed consent.

You may not qualify if:

• active sepsis;
• cardiac function impairment (history of previous heart failure or 40% ejection fraction);
• renal impairment (serum creatinine \>1.5 normal value or creatinine clearance 60 ml/min);
• liver function impairment (aspartate aminotransferase, alanine aminotransferase, bilirubin \> 1.5 normal value);
• bone marrow function impairment (leukocytes 4000 / mm3, neutrophils 1500 /mm3, platelets 80000/mm3);
• lung function impairment (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);
• extra-abdominal and/or hepatic metastases at the Computed Tomography scan of the chest, abdomen and pelvis with intravenous contrast;
• severe complications (grade 3-4) after primary cancer surgery;
• haemorrhagic diathesis or coagulopathy;
• pregnancy or lactation in progress;
• psychiatric or neurological conditions such as to preclude protocol procedures; 12) contraindications to laparoscopy; 13) known hypersensitivity to oxaliplatin or other platinum containing compounds and/or to any of their excipients; 14) history of previous malignancies treated in the last three years, excluding cutaneous spinocellular carcinoma and/or basocellular carcinoma; 15) prior pre-operative radio-chemotherapy..

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

RECRUITING

Study Officials

• Dario Baratti, MD

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dario Baratti, MD

CONTACT

+390223901; dario.baratti@istitutotumori.mi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 19, 2023
• Study Start: April 30, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: after the completion of the study, for additional 60 months
• Access Criteria: upon reasonable request to the principal investigator

Locations

IT (1)