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PIPAC for the Treatment of Colorectal Peritoneal Metastases

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ClinicalTrials.gov Identifier: NCT03868228
Recruitment Status : Recruiting
First Posted : March 11, 2019
Last Update Posted : July 31, 2020
Sponsor:
Collaborator:
Barts Cancer Institute
Information provided by (Responsible Party):
Imperial College London

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Peritoneal Metastases Procedure: Pressurised Intraperitoneal Aerosol Chemotherapy (PIPAC) Phase 1 Phase 2

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 of the abdomen).

Patients diagnosed with peritoneal metastases usually first undertake a period of neoadjuvant systemic chemotherapy prior to consideration of cytoreductive surgery and subsequent hyperthermic intraperitoneal chemotherapy (CRS-HIPEC). If the extent of peritoneal disease remains too significant then CRS-HIPEC is contraindicated.

Not all patients are suitable for cytoreductive surgery and subsequent hyperthermic intraperitoneal chemotherapy (CRS-HIPEC). CRS-HIPEC involves a large cut down the length of the abdomen, surgery to cut away as many of the structures affected by cancer as possible then the bathing the abdomen in heated chemotherapy. This is associated with a considerable risk of complications and a not insignificant risk of death. As such there is a significant unmet need for less invasive effective treatments for patients with extensive colorectal peritoneal metastases (CPM).

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.

It is an additional treatment to the standard intravenous or oral chemotherapy which would otherwise be administered in isolation for the selected patients. PIPAC would be administered across multiple sessions assuming no disease progression was identified. It can be used in patients undertaking neo-adjuvant systemic chemotherapy before CRS- HIPEC or used throughout treatment for those patients deemed not suitable for CRS-HIPEC.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study Assessing the Efficacy of Oxaliplatin Based Pressurised IntraPeritoneal Aerosol Chemotherapy (PIPAC) for the Treatment of Colorectal Peritoneal Metastases
Actual Study Start Date : February 5, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment with PIPAC
Patients with colorectal cancer and peritoneal metastases being treated with pressurised intraperitoneal aerosol chemotherapy (PIPAC)
 Procedure: Pressurised Intraperitoneal Aerosol Chemotherapy (PIPAC)
Use of CapnoPen device to aerosolise Oxaliplatin 92mg/m2 chemotherapy 6-8 weekly intervals for intraperitoneal distribution via laparoscopy.
Other Name: CapnoPen


Outcome Measures
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Primary Outcome Measures :
  1. Progression free survival assessed by laparoscopy and cross sectional imaging [ Time Frame: 2 year follow up or until death ]

Secondary Outcome Measures :
  1. Quality of life assessments - QLQ-C30 questionnaire [ Time Frame: Repeated 6-8 weekly before each PIPAC treatment. Trend correlated over period of trial until end of September 2021 and reported thereafter ]
    European Organisation for Research and Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ-C30 Verison 3). Range 0-100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.

  2. Serious CTCAE adverse events / operative complications related to PIPAC [ Time Frame: 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 ]
    Common Terminology Criteria for Adverse Events (CTCAE). Grade 1-5 with higher indicating more severe.

  3. PIPAC related safety regulation breaches / adverse events in theatre [ Time Frame: Assessed following each PIPAC treatment 6-8 weekly. Ultimately reported at end of trial September 2021 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with CPM with expected life expectancy of > 6 months.
  2. ECOG Scale of Performance Status (PS) scores 0 or 1.
  3. 15 mile catchment area to facilitate overseeing systemic chemotherapy administration
  4. Concomitant systemic chemotherapy regimens with FOLFIRI, FOLFOX, Mitomycin C & Fluorouracil, Capecitabine (excluding Lonsurf) or without systemic chemotherapy if no systemic options available to patient
  5. Neutrophil count on or just before chemotherapy due date of >1.5

Exclusion Criteria:

  1. Age <18
  2. MDT decision that patient not suitable for PIPAC
  3. Decision by Preoperative Assessment Department or Consultant Anaesthetist that patient not fit for general anaesthesia and / or laparoscopy
  4. Clinically evident gross ascites
  5. Bowel obstruction
  6. Bevacizumab as part of systemic chemotherapy regime - time from chemotherapy to surgery would be too long for PIPAC to be feasible
  7. Previous bone marrow suppression due to chemotherapy given risk of post-operative neutropenia
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03868228


Contacts
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Contact: Jamie Murphy 020 7886 1110 judith.macdonald1@nhs.net

Locations
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United Kingdom
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom, W2 1NY
Contact: Jamie Murphy    020 3312 6666    peter.kyle@nhs.net   
Sub-Investigator: Peter Kyle         
Principal Investigator: Jamie Murphy         
Sponsors and Collaborators
Imperial College London
Barts Cancer Institute
More Information
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03868228    
Other Study ID Numbers: 239718
239718 ( Other Identifier: IRAS )
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Imperial College London:
intraperitoneal chemotherapy
PIPAC
pressurised
colorectal cancer
peritoneal metastases
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Colorectal Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Intestinal Neoplasms
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases