Clinical trial NCT06091683: Adjuvant Pressurized Intraperitoneal Aerosol Chemotherapy to Prevent Colorectal Peritoneal Metastases (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
Overall status: RECRUITING
Phase: NA
Conditions: Peritoneal Metastases From Colorectal Cancer
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Histopathological diagnosis of intestinal type, mucinous or signet ring cell adenocarcinoma of the colon (with upper limit of the tumor above peritoneal reflection);
2. curative (microscopically complete) surgery performed by laparotomy or laparoscopy;
3. 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);
4. age \> 18;
5. performance status 2 according to the World Health Organization score;
6. willingness to start adjuvant systemic chemotherapy and post-operative follow-up;
7. Signing of informed consent.

Exclusion Criteria:

1. active sepsis;
2. cardiac function impairment (history of previous heart failure or 40% ejection fraction);
3. renal impairment (serum creatinine \>1.5 normal value or creatinine clearance 60 ml/min);
4. liver function impairment (aspartate aminotransferase, alanine aminotransferase, bilirubin \> 1.5 normal value);
5. bone marrow function impairment (leukocytes 4000 / mm3, neutrophils 1500 /mm3, platelets 80000/mm3);
6. 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);
7. extra-abdominal and/or hepatic metastases at the Computed Tomography scan of the chest, abdomen and pelvis with intravenous contrast;
8. severe complications (grade 3-4) after primary cancer surgery;
9. haemorrhagic diathesis or coagulopathy;
10. pregnancy or lactation in progress;
11. 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..

Primary outcomes:
measure: Feasibility of adjuvant pressurized intraperitoneal aerosol chemotherapy (PIPAC)
timeFrame: 12 weeks
measure: Safety of adjuvant pressurized intraperitoneal aerosol chemotherapy (PIPAC)
timeFrame: 30 days
Secondary outcomes:
measure: Overall survival
timeFrame: 60 months
measure: Disease-free survival
timeFrame: 60 months
measure: Peritoneal disease-free survival
timeFrame: 60 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
Study officials:
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy
name: Dario Baratti, MD
role: PRINCIPAL_INVESTIGATOR
References: