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Trial Title:
Adjuvant Pressurized Intraperitoneal Aerosol Chemotherapy to Prevent Colorectal Peritoneal Metastases (ProphyPIPAC)
NCT ID:
NCT06091683
Condition:
Peritoneal Metastases From Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Neoplasm Metastasis
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Pressurized intraperitoneal aerosol chemotherapy (PIPAC)
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.
Arm group label:
Adjuvant pressurized intraperitoneal aerosol chemotherapy (PIPAC)
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.
Criteria for 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..
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei Tumori
Address:
City:
Milano
Zip:
20133
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Dario Baratti, MD
Phone:
+390223903441
Email:
dario.baratti@istitutotumori.mi.it
Start date:
April 30, 2021
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Agency class:
Other
Source:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06091683
