Clinical trial NCT03868228: PIPAC for the Treatment of Colorectal Peritoneal Metastases
Official title: Pilot Study Assessing the Efficacy of Oxaliplatin Based Pressurised IntraPeritoneal Aerosol Chemotherapy (PIPAC) for the Treatment of Colorectal Peritoneal Metastases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Colorectal Neoplasms
Peritoneal Metastases
Keywords: intraperitoneal chemotherapy
PIPAC
pressurised
colorectal cancer
peritoneal metastases
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Barts Cancer Institute
First posted: 2019-03-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Progression free survival assessed by laparoscopy and cross sectional imaging
timeFrame: 2 year follow up or until death
Secondary outcomes:
measure: Quality of life assessments - QLQ-C30 questionnaire
timeFrame: Repeated 6-8 weekly before each PIPAC treatment. Trend correlated over period of trial until end of September 2021 and reported thereafter
measure: Serious CTCAE adverse events / operative complications related to PIPAC
timeFrame: 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
measure: PIPAC related safety regulation breaches / adverse events in theatre
timeFrame: Assessed following each PIPAC treatment 6-8 weekly. Ultimately reported at end of trial September 2021
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
References: