Colorectal NeoplasmsPhase 1/2NCT03868228
PIPAC for the Treatment of Colorectal Peritoneal Metastases
A Phase 1/2 study testing Pressurised Intraperitoneal Aerosol Chemotherapy (PIPAC) in people with Colorectal Neoplasms and Peritoneal Metastases, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Peritoneal Metastases
- What is being tested?
- Pressurised Intraperitoneal Aerosol Chemotherapy (PIPAC)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Feb 2019to 30 Sep 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College Healthcare NHS Trust
London, W2 1NY
Jamie Murphy, 020 3312 6666, peter.kyle@nhs.net
Peter Kyle
About this study
Official title: Pilot Study Assessing the Efficacy of Oxaliplatin Based Pressurised IntraPeritoneal Aerosol Chemotherapy (PIPAC) for the Treatment of Colorectal Peritoneal Metastases
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.
Read the 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.
- Conditions
- Colorectal Neoplasms, Peritoneal Metastases
- Being tested
- Pressurised Intraperitoneal Aerosol Chemotherapy (PIPAC)
- Keywords
- intraperitoneal chemotherapy, PIPAC, pressurised, colorectal cancer, peritoneal metastases
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressurised Intraperitoneal Aerosol Chemotherapy (PIPAC)Procedure or surgery
Also called CapnoPen
Use of CapnoPen device to aerosolise Oxaliplatin 92mg/m2 chemotherapy 6-8 weekly intervals for intraperitoneal distribution via laparoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with PIPAC | Experimental | Patients with colorectal cancer and peritoneal metastases being treated with pressurised intraperitoneal aerosol chemotherapy (PIPAC) Receives: Procedure: Pressurised Intraperitoneal Aerosol Chemotherapy (PIPAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival assessed by laparoscopy and cross sectional imaging
Measured: 2 year follow up or until death
Secondary outcomes (3)
Quality of life assessments - QLQ-C30 questionnaire
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.
Measured: 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
Common Terminology Criteria for Adverse Events (CTCAE). Grade 1-5 with higher indicating more severe.
Measured: 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
Measured: Assessed following each PIPAC treatment 6-8 weekly. Ultimately reported at end of trial September 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start5 Feb 2019
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Barts Cancer Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868228
- Sponsor's protocol ID
- 239718
- Other IDs
- 239718
- Status last verified
- Sep 2022
- First submitted
- 6 Mar 2019
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Assessing the Efficacy of Oxaliplatin Based Pressurised IntraPeritoneal Aerosol Chemotherapy (PIPAC) for the Treatment of Colorectal Peritoneal Metastases
- ClinicalTrials.gov ID
- NCT03868228
- Acronym / sponsor ID
- 239718
- Conditions
- Colorectal Neoplasms, Peritoneal Metastases
- Keywords
- intraperitoneal chemotherapy, PIPAC, pressurised, colorectal cancer, peritoneal metastases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Barts Cancer Institute
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with PIPAC | Experimental | Procedure: Pressurised Intraperitoneal Aerosol Chemotherapy (PIPAC)Patients with colorectal cancer and peritoneal metastases being treated with pressurised intraperitoneal aerosol chemotherapy (PIPAC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pressurised Intraperitoneal Aerosol Chemotherapy (PIPAC)Also: CapnoPenUse of CapnoPen device to aerosolise Oxaliplatin 92mg/m2 chemotherapy 6-8 weekly intervals for intraperitoneal distribution via laparoscopy. | Procedure or surgery | Treatment with PIPAC |
Primary outcome
Progression free survival assessed by laparoscopy and cross sectional imaging
Time frame: 2 year follow up or until death
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pressurised Intraperitoneal Aerosol Chemotherapy (PIPAC) in people with Colorectal Neoplasms and Peritoneal Metastases, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jamie Murphy (020 7886 1110, judith.macdonald1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival assessed by laparoscopy and cross sectional imaging (time frame: 2 year follow up or until death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.