PIPAC for the Treatment of Colorectal Peritoneal Metastases

NCT03868228 | Unknown Phase 1

• 1 other identifier: 239718
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study would like to assess the efficacy of pressurised intraperitoneal aerosol chemotherapy (PIPAC). This technique delivers chemotherapy directly into the abdomen via a less invasive laparoscopic or 'keyhole' form of surgery. This type of chemotherapy takes the form of an aerosol, similar to the spray of a deodorant for example. The aerosol is administered into the abdomen under pressure, pushing the chemotherapy deeper into the tissues and cancer. This approach does not involve any surgical removal of the cancer.

Conditions

Colorectal Neoplasms; Peritoneal Metastases

Keywords

intraperitoneal chemotherapy; PIPAC; pressurised; colorectal cancer; peritoneal metastases

Outcome Measures

Primary Outcomes (1)

• Progression free survival assessed by laparoscopy and cross sectional imaging

  2 year follow up or until death

Secondary Outcomes (3)

• Quality of life assessments - QLQ-C30 questionnaire

  Repeated 6-8 weekly before each PIPAC treatment. Trend correlated over period of trial until end of September 2021 and reported thereafter

• Serious CTCAE adverse events / operative complications related to PIPAC

  CTCAE assessed following each PIPAC treatment 6-8 weekly and 90 day period thereafter. Will be fully reported at end of trial September 2021, but any Grades 3, 4 and 5 will be notified contemporaneously

• PIPAC related safety regulation breaches / adverse events in theatre

  Assessed following each PIPAC treatment 6-8 weekly. Ultimately reported at end of trial September 2021

Study Arms (1)

Treatment with PIPAC

EXPERIMENTAL

Patients with colorectal cancer and peritoneal metastases being treated with pressurised intraperitoneal aerosol chemotherapy (PIPAC)

Procedure: Pressurised Intraperitoneal Aerosol Chemotherapy (PIPAC)

Interventions

Pressurised Intraperitoneal Aerosol Chemotherapy (PIPAC) PROCEDURE

Use of CapnoPen device to aerosolise Oxaliplatin 92mg/m2 chemotherapy 6-8 weekly intervals for intraperitoneal distribution via laparoscopy.

Also known as: CapnoPen

Treatment with PIPAC

Eligibility Criteria

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

You may qualify if:

• Patients with CPM with expected life expectancy of \> 6 months.
• ECOG Scale of Performance Status (PS) scores 0 or 1.
• mile catchment area to facilitate overseeing systemic chemotherapy administration
• Concomitant systemic chemotherapy regimens with FOLFIRI, FOLFOX, Mitomycin C \& Fluorouracil, Capecitabine (excluding Lonsurf) or without systemic chemotherapy if no systemic options available to patient
• Neutrophil count on or just before chemotherapy due date of \>1.5

You may not qualify if:

• Age \<18
• MDT decision that patient not suitable for PIPAC
• Decision by Preoperative Assessment Department or Consultant Anaesthetist that patient not fit for general anaesthesia and / or laparoscopy
• Clinically evident gross ascites
• Bowel obstruction
• Bevacizumab as part of systemic chemotherapy regime - time from chemotherapy to surgery would be too long for PIPAC to be feasible
• Previous bone marrow suppression due to chemotherapy given risk of post-operative neutropenia

Sponsors & Collaborators

• Imperial College London: lead
• Barts Cancer Institute: collaborator

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Jamie Murphy

CONTACT

020 7886 1110; judith.macdonald1@nhs.net

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 11, 2019
• Study Start: February 5, 2019
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)