Back to resultsAdjuvant Pressurized Intraperitoneal Aerosol Chemotherapy to Prevent Colorectal Peritoneal Metastases (ProphyPIPAC) (ProphyPIPAC)
Primary Purpose
Peritoneal Metastases From Colorectal Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Pressurized intraperitoneal aerosol chemotherapy (PIPAC)
Sponsored by
About this trial
This is an interventional treatment trial for Peritoneal Metastases From Colorectal Cancer
Eligibility Criteria
Inclusion Criteria: 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; 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. Exclusion Criteria: 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); 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..
Sites / Locations
- Fondazione IRCCS Istituto Nazionale dei TumoriRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adjuvant pressurized intraperitoneal aerosol chemotherapy (PIPAC)
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Peritoneal disease-free survival
Peritoneal disease-free survival will be measured from the date of primary surgery to the date of peritoneal metastasis diagnosis,
Full Information
NCT ID
NCT06091683
First Posted
October 16, 2023
Last Updated
October 16, 2023
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
1. Study Identification
Unique Protocol Identification Number
NCT06091683
Brief Title
Adjuvant Pressurized Intraperitoneal Aerosol Chemotherapy to Prevent Colorectal Peritoneal Metastases (ProphyPIPAC)
Acronym
ProphyPIPAC
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Metastases From Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adjuvant pressurized intraperitoneal aerosol chemotherapy (PIPAC)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Pressurized intraperitoneal aerosol chemotherapy (PIPAC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of adjuvant pressurized intraperitoneal aerosol chemotherapy (PIPAC)
Description
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.
Time Frame
12 weeks
Title
Safety of adjuvant pressurized intraperitoneal aerosol chemotherapy (PIPAC)
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Overall survival
Description
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.
Time Frame
60 months
Title
Disease-free survival
Description
Disease-free survival will be measured from the date of primary surgery to the date of peritoneal metastasis diagnosis, systemic metastases or death.
Time Frame
60 months
Title
Peritoneal disease-free survival
Description
Peritoneal disease-free survival will be measured from the date of primary surgery to the date of peritoneal metastasis diagnosis,
Time Frame
60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
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.
Exclusion Criteria:
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);
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..
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dario Baratti, MD
Phone
+390223901
Ext
3441
Email
dario.baratti@istitutotumori.mi.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dario Baratti, MD
Organizational Affiliation
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dario Baratti, MD
Phone
+390223903441
Email
dario.baratti@istitutotumori.mi.it
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
I confirm that we have a plan to make individual participant data (IPD) available to other researchers through publicly available database
IPD Sharing Time Frame
after the completion of the study, for additional 60 months
IPD Sharing Access Criteria
upon reasonable request to the principal investigator
Learn more about this trial
Adjuvant Pressurized Intraperitoneal Aerosol Chemotherapy to Prevent Colorectal Peritoneal Metastases (ProphyPIPAC)
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