Using aerosol chemotherapy to prevent colorectal cancer spread after surgery

Pilot Study of Adjuvant Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) for the Prevention of Peritoneal Metastases After Curative-intent Surgery for High-risk Colorectal Cancer.

This study is testing if a new type of aerosol chemotherapy can help prevent colorectal cancer from coming back after surgery in patients at high risk for it.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Milano)
• Trial ID: NCT06091683 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the feasibility and safety of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in patients who have undergone curative surgery for high-risk colorectal cancer. Participants will receive PIPAC treatment 4 to 8 weeks post-surgery, followed by standard adjuvant systemic chemotherapy. The study will monitor patients for adverse events, survival rates, disease relapse, and quality of life over time. It is a single-arm, single-center, open-label trial focused on patients with specific risk factors for peritoneal metastases.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with specific types of colorectal cancer who have undergone curative surgery and have risk factors for metastases.

Not a fit: Patients with active sepsis, significant cardiac or renal impairment, or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of peritoneal metastases in colorectal cancer patients after surgery.

How similar studies have performed: While the use of PIPAC is a novel approach, similar studies have shown promising results in treating peritoneal metastases, indicating potential for success.

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..

Where this trial is running

Milano

• Fondazione IRCCS Istituto Nazionale dei Tumori — Milano, Italy (Recruiting)

Study contacts

• Principal investigator: Dario Baratti, MD — Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy
• Study coordinator: Dario Baratti, MD

Conditions Peritoneal Metastases From Colorectal Cancer