Status:
UNKNOWN
PIPAC for the Treatment of Colorectal Peritoneal Metastases
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Barts Cancer Institute
Conditions:
Colorectal Neoplasms
Peritoneal Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 laparoscopi...
Detailed Description
This study aims to assess the efficacy of a novel intervention for advanced colorectal cancers with peritoneal metastases (i.e. cancers of the colon or rectum which have spread to the internal lining ...
Eligibility Criteria
Inclusion
- Patients with CPM with expected life expectancy of \> 6 months.
- ECOG Scale of Performance Status (PS) scores 0 or 1.
- 15 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
Exclusion
- 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
Key Trial Info
Start Date :
February 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03868228
Start Date
February 5 2019
End Date
September 30 2024
Last Update
September 28 2022
Active Locations (1)
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1
Imperial College Healthcare NHS Trust
London, United Kingdom, W2 1NY