Peritoneal Metastases From Colorectal CancerProphyPIPACNCT06091683
Adjuvant Pressurized Intraperitoneal Aerosol Chemotherapy to Prevent Colorectal Peritoneal Metastases (ProphyPIPAC)
A study testing Pressurized intraperitoneal aerosol chemotherapy (PIPAC) in people with Peritoneal Metastases From Colorectal Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
Trial summary
The objective of this clinical trial is to demonstrate the feasibility and safety of pressurized intraperitoneal aerosol chemotherapy (PIPAC) for the prevention of peritoneal metastases after curative-intent surgery for high-risk colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peritoneal Metastases From Colorectal Cancer
- What is being tested?
- Pressurized intraperitoneal aerosol chemotherapy (PIPAC)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 30 Apr 2021to 31 Dec 2025
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathological diagnosis of intestinal type, mucinous or signet ring cell adenocarcinoma of the colon (with upper limit of the tumor above peritoneal reflection);
- curative (microscopically complete) surgery performed by laparotomy or laparoscopy;
- presence of at least one of the following risk factors for the development of metachronous peritoneal metastases:
- perforated primary tumor (any T, N0-2b, M0);
- primary tumor infiltrating the visceral peritoneum (pT4a, N0-2b, M0), or directly invading adjacent organs (pT4b, N0-2b, M0);
- age > 18;
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- performance status 2 according to the World Health Organization score;
- willingness to start adjuvant systemic chemotherapy and post-operative follow-up;
- Signing of informed consent.
Who cannot join
- active sepsis;
- cardiac function impairment (history of previous heart failure or 40% ejection fraction);
- renal impairment (serum creatinine >1.5 normal value or creatinine clearance 60 ml/min);
- liver function impairment (aspartate aminotransferase, alanine aminotransferase, bilirubin > 1.5 normal value);
- bone marrow function impairment (leukocytes 4000 / mm3, neutrophils 1500 /mm3, platelets 80000/mm3);
- lung function impairment (diagnosis of severe chronic obstructive pulmonary disease or 50% forced expiratory volume at one second or 40% diffusion capacity of lung for carbon monoxide adjusted for age);
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- extra-abdominal and/or hepatic metastases at the Computed Tomography scan of the chest, abdomen and pelvis with intravenous contrast;
- severe complications (grade 3-4) after primary cancer surgery;
- haemorrhagic diathesis or coagulopathy;
- pregnancy or lactation in progress;
- psychiatric or neurological conditions such as to preclude protocol procedures; 12) contraindications to laparoscopy; 13) known hypersensitivity to oxaliplatin or other platinum containing compounds and/or to any of their excipients; 14) history of previous malignancies treated in the last three years, excluding cutaneous spinocellular carcinoma and/or basocellular carcinoma; 15) prior pre-operative radio-chemotherapy..
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Dario Baratti, MD, +390223903441, dario.baratti@istitutotumori.mi.it
About this study
Official title: Pilot Study of Adjuvant Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) for the Prevention of Peritoneal Metastases After Curative-intent Surgery for High-risk Colorectal Cancer.
The objective of this clinical trial is to demonstrate the feasibility and safety of pressurized intraperitoneal aerosol chemotherapy (PIPAC) for the prevention of peritoneal metastases after curative-intent surgery for high-risk colorectal cancer.
Read the detailed description
This single-arm, single-center, open-label trial enrolls patients after curative-intent surgery for colon adenocarcinoma (proximal to peritoneal reflection), intestinal or mucinous histological type, associated with the following clinical-pathological risk factors for the development of peritoneal metastases: a) stage pT4a, N0-2b, M0 of the Tumor Node Metastasis classification; b) stage pT4b, N0-2b, M0; and c) primary perforated tumor (any T, any N, M0). Eligible patients who will give informed consent undergo laparoscopic pressurized intraperitoneal aerosol chemotherapy (PIPAC) 4 to 8 weeks after primary surgery, followed by adjuvant systemic chemotherapy according to according to current guidelines. After the procedure, patients will be followed-up to assess occurrence of adverse events,survival, peritoneal and systemic disease relapse, and quality of life.
- Being tested
- Pressurized intraperitoneal aerosol chemotherapy (PIPAC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressurized intraperitoneal aerosol chemotherapy (PIPAC)Procedure or surgery
Laparoscopic exploration of the abdominal cavity with dissection of adhesions and biopsies of suspect findings (if needed).
PIPAC will be administered with oxaliplatin (92 mg/m2 body surface area in 150 ml dextrose solution) for 30 minutes under the following spraying conditions: cytostatic application at a rate of 30 ml/min, pressure of 1380 kilo-pascal over 30 minutes, and temperature of 22°C. One hour before the beginning of PIPAC, intravenous infusion of 5-fluorouracil (400 mg/m2) and folinic acid (20mg/m2) will be initiated. Standard protectionist procedures will be adopted to avoid contamination of operators and the environment with nebulized chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant pressurized intraperitoneal aerosol chemotherapy (PIPAC) | Experimental | Preliminary laparoscopic exploration of the abdominal cavity and adjuvant pressurized intraperitoneal aerosol chemotherapy (PIPAC) with oxaliplatin and concurrent intravenous infusion of 5-fluorouracil and folinic acid. Receives: Procedure: Pressurized intraperitoneal aerosol chemotherapy (PIPAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of adjuvant pressurized intraperitoneal aerosol chemotherapy (PIPAC)
The adjuvant PIPAC performed in an early setting after primary surgery will be considered feasible if:
- the laparoscopic procedure can be completed in 9 patients;
- the postoperative stay will be three days or shorter in ≥6 patients;
- the post-operative adjuvant s-CT will begin within 12 weeks of primary surgery in ≥ 9 patients.
Measured: 12 weeks
Safety of adjuvant pressurized intraperitoneal aerosol chemotherapy (PIPAC)
The adjuvant PIPAC will be considered a well tolerated procedure if:
- a maximum of one serious treatment-related complication will occur;
- a maximum of one laparotomy conversion will occur;
- a maximum of one hospital readmission will occur within 30 days.
Measured: 30 days
Secondary outcomes (3)
Overall survival
Overall survival will be measured from the date of primary surgery to the date of death for any cause or, for patients still alive at the date of the last available follow-up.
Measured: 60 months
Disease-free survival
Disease-free survival will be measured from the date of primary surgery to the date of peritoneal metastasis diagnosis, systemic metastases or death.
Measured: 60 months
Peritoneal disease-free survival
Peritoneal disease-free survival will be measured from the date of primary surgery to the date of peritoneal metastasis diagnosis,
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start30 Apr 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal Metastases From Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dario Baratti, MD, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091683
- Sponsor's protocol ID
- INT 0068/20
- Other IDs
- 2020-000604-11, BRI D/17/1DB, SC 2020-000604-11_ID_18605
- Acronym
- ProphyPIPAC
- Status last verified
- Oct 2023
- First submitted
- 16 Oct 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I confirm that we have a plan to make individual participant data (IPD) available to other researchers through publicly available database
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Adjuvant Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) for the Prevention of Peritoneal Metastases After Curative-intent Surgery for High-risk Colorectal Cancer.
- ClinicalTrials.gov ID
- NCT06091683
- Acronym / sponsor ID
- ProphyPIPAC / INT 0068/20
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Oct 2023 (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.
The objective of this clinical trial is to demonstrate the feasibility and safety of pressurized intraperitoneal aerosol chemotherapy (PIPAC) for the prevention of peritoneal metastases after curative-intent surgery for high-risk colorectal cancer.
Detailed description
This single-arm, single-center, open-label trial enrolls patients after curative-intent surgery for colon adenocarcinoma (proximal to peritoneal reflection), intestinal or mucinous histological type, associated with the following clinical-pathological risk factors for the development of peritoneal metastases: a) stage pT4a, N0-2b, M0 of the Tumor Node Metastasis classification; b) stage pT4b, N0-2b, M0; and c) primary perforated tumor (any T, any N, M0). Eligible patients who will give informed consent undergo laparoscopic pressurized intraperitoneal aerosol chemotherapy (PIPAC) 4 to 8 weeks after primary surgery, followed by adjuvant systemic chemotherapy according to according to current guidelines. After the procedure, patients will be followed-up to assess occurrence of adverse events,survival, peritoneal and systemic disease relapse, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adjuvant pressurized intraperitoneal aerosol chemotherapy (PIPAC) | Experimental | Procedure: Pressurized intraperitoneal aerosol chemotherapy (PIPAC)Preliminary laparoscopic exploration of the abdominal cavity and adjuvant pressurized intraperitoneal aerosol chemotherapy (PIPAC) with oxaliplatin and concurrent intravenous infusion of 5-fluorouracil and folinic acid. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histopathological diagnosis of intestinal type, mucinous or signet ring cell adenocarcinoma of the colon (with upper limit of the tumor above peritoneal reflection);
- curative (microscopically complete) surgery performed by laparotomy or laparoscopy;
- presence of at least one of the following risk factors for the development of metachronous peritoneal metastases:
- age > 18;
- performance status 2 according to the World Health Organization score;
Key exclusion criteria (11 listed)
- active sepsis;
- cardiac function impairment (history of previous heart failure or 40% ejection fraction);
- renal impairment (serum creatinine >1.5 normal value or creatinine clearance 60 ml/min);
- liver function impairment (aspartate aminotransferase, alanine aminotransferase, bilirubin > 1.5 normal value);
- bone marrow function impairment (leukocytes 4000 / mm3, neutrophils 1500 /mm3, platelets 80000/mm3);
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 |
|---|---|---|
| Pressurized intraperitoneal aerosol chemotherapy (PIPAC)Laparoscopic exploration of the abdominal cavity with dissection of adhesions and biopsies of suspect findings (if needed). PIPAC will be administered with oxaliplatin (92 mg/m2 body surface area in 150 ml dextrose solution) for 30 minutes under the following spraying conditions: cytostatic application at a rate of 30 ml/min, pressure of 1380 kilo-pascal over 30 minutes, and temperature of 22°C. One hour before the beginning of PIPAC, intravenous infusion of 5-fluorouracil (400 mg/m2) and folinic acid (20mg/m2) will be initiated. Standard protectionist procedures will be adopted to avoid contamination of operators and the environment with nebulized chemotherapy. | Procedure or surgery | Adjuvant pressurized intraperitoneal aerosol chemotherapy (PIPAC) |
Primary outcome
Feasibility of adjuvant pressurized intraperitoneal aerosol chemotherapy (PIPAC)
Time frame: 12 weeks
The adjuvant PIPAC performed in an early setting after primary surgery will be considered feasible if: * the laparoscopic procedure can be completed in 9 patients; * the postoperative stay will be three days or shorter in ≥6 patients; * the post-operative adjuvant s-CT will begin within 12 weeks of primary surgery in ≥ 9 patients.
Safety of adjuvant pressurized intraperitoneal aerosol chemotherapy (PIPAC)
Time frame: 30 days
The adjuvant PIPAC will be considered a well tolerated procedure if: * a maximum of one serious treatment-related complication will occur; * a maximum of one laparotomy conversion will occur; * a maximum of one hospital readmission will occur within 30 days.
3 secondary outcomes
Overall survival
Time frame: 60 months
Disease-free survival
Time frame: 60 months
Peritoneal disease-free survival
Time frame: 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Individual participant dataSharing planned: Yes. I confirm that we have a plan to make individual participant data (IPD) available to other researchers through publicly available database
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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.
Dario Baratti, MD principal investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pressurized intraperitoneal aerosol chemotherapy (PIPAC) in people with Peritoneal Metastases From Colorectal Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
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 9 inclusion and 11 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 19 Oct 2023. 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 Italy. 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.
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 Dario Baratti, MD (+390223901 ext. 3441, dario.baratti@istitutotumori.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of adjuvant pressurized intraperitoneal aerosol chemotherapy (PIPAC) (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 19 Oct 2023.