Phase II study of adjuvant pressurized intraperitoneal aerosol chemotherapy (PIPAC) for the prevention of peritoneal metastases after curative-intent surgery for high-risk colorectal cancer.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fondazione IRCCS Istituto Nazionale Dei Tumori

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

24 Nov 2020 → ongoing

Decision date (initial)

2024-06-18

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-513376-17-00

EudraCT number

2020-000604-11

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Primary Objective of this study is to demonstrate the effectiveness of adjuvant PIPAC performed within 4-8 weeks after curative-intent surgery, and followed by adjuvant s-CT, in preventing the onset of PM in high risk colon cancer.

Secondary objectives 1

1. Secondary Objectives are to assess feasibility, toxicity and impact on the quality of life (QoV) of the adjuvant PIPAC, performed in an early setting (within 4-8 weeks of primitive surgery), overall survival, disease-free survival (peritoneal and distant), and pattern of disease progression after the procedure.

Conditions and MedDRA coding

colorectal cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

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 metacrhonous PM: • 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 WHO score
6. willingness to start adjuvant s-CT and post-operative follow-up
7. Signing of informed consent.

Exclusion criteria 15

1. active sepsis
2. cardiac function impairment (history of previous heart failure or 40% FE); 3. renal impairment (serum creatinine >1.5 normal value or creatinine clearance 60 ml/min)
3. liver function impairment (AST, ALT, bilirubin > 1.5 normal value)
4. bone marrow function impairment (leukocytes 4000 / mm3, neutrophils 1500 /mm3, platelets 80000/mm3)
5. lung function impairment (diagnosis of severe COPD or 50% FEV1 or 40% DLCO adjusted for age)
6. renal impairment (serum creatinine >1.5 normal value or creatinine clearance 60 ml/min)
7. extra-abdominal and/or hepatic metastases at the CT 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
15. spinocellular carcinoma and/or basocellular carcinoma; prior pre-operative radio-chemotherapy.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The efficacy of adjuvant PIPAC will be assessed by measuring peritoneal metastasis-free survival from the date of primary surgery to the date of MP diagnosis.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fondazione IRCCS Istituto Nazionale Dei Tumori

Sponsor organisation

Fondazione IRCCS Istituto Nazionale Dei Tumori

Address

Via Giacomo Venezian 1

City

Milan

Postcode

20133

Country

Italy

Scientific contact point

Organisation

Fondazione IRCCS Istituto Nazionale Dei Tumori

Contact name

Clinical Trials Center

Public contact point

Organisation

Fondazione IRCCS Istituto Nazionale Dei Tumori

Contact name

Clinical Trials Center

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications