Personalized chemotherapy for colorectal cancer spread in the abdomen

Organoids From Colorectal Peritoneal Metastases to Improve Cytoreductive Surgery and Patient-tailored Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

This study is testing a new way to personalize chemotherapy for people with colorectal cancer that has spread in the abdomen by using their own tumor cells to find the best treatment before surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 24 (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: NCT06057298 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with limited and surgically resectable peritoneal metastases from colorectal cancer, without distant metastases.

Not a fit: Patients with extensive peritoneal disease or those with significant comorbidities that contraindicate major surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective treatment options and improved survival rates for patients with colorectal peritoneal metastases.

How similar studies have performed: While the use of organoids for personalized treatment is a novel approach, similar studies have shown promise in tailoring chemotherapy regimens based on individual tumor biology.

Eligibility criteria

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 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