Personalized chemotherapy for colorectal cancer spread in the abdomen

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to improve treatment outcomes for patients with peritoneal metastases from colorectal cancer by using patient-derived organoids to tailor hyperthermic intraperitoneal chemotherapy (HIPEC). After confirming the diagnosis through a preliminary laparoscopy, patients will undergo a preoperative systemic chemotherapy regimen. The effectiveness of various chemotherapy drugs will be tested on organoids derived from the patient's tumor to select the most effective treatment before surgery. The goal is to enhance the efficacy of HIPEC and reduce the risk of disease relapse.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. diagnosis of peritoneal metastases from intestinal-type or mucinous colo-rectal adenocarcinoma, by histological/cytological confirmation.
2. limited to moderate peritoneal involvement: peritoneal cancer index (PCI) ≤ 20;
3. peritoneal disease potentially amenable to complete surgical cytoreduction;
4. no evidence of hepatic, extra-regional nodal, or extra abdominal metastases
5. World Health Organization (WHO) performance status ≤2;
6. willingness to undergo preliminary laparoscopy, perioperative s-CT, and post-operative follow-up;
7. signature of informed consent.

Exclusion Criteria:

1. active sepsis;
2. impaired cardiac function (history of previous heart failure or 40% ejection fraction);
3. impaired renal function (serum creatinine \>1.5 normal value or creatinine clearance \< 60 ml/min);
4. impaired liver function (aspartate aminotransferase, alanine aminotransferase, bilirubin \> 1.5 normal value);
5. impaired bone marrow function (leukocytes \<4000/mm3, neutrophils \<1500/mm3, platelets \<80000/mm3);
6. impaired lung function (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. dehydropyrimidine dehydrogenase deficiency;
8. pregnancy or lactation in progress;
9. haemorrhagic diathesis or coagulopathy;
10. any other condition or comorbidity that prevents safe administration of systemic chemotherapy (e.g. severe diarrhea, stomatitis or ulceration in the mouth or gastrointestinal tract);
11. psychiatric or neurological conditions that preclude the procedures of the protocol;
12. any contraindication to laparoscopy;
13. known hypersensitivity to any of the chemotherapy agents used for HIPEC in the present study 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. previous cytoreductive surgery and HIPEC

Where it's running

• 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
• Email: dario.baratti@istitutotumori.mi.it
• Phone: +390223901

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Can hepatic artery infusion chemotherapy enable liver surgery for colorectal cancer that has spread to the liver?

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.