Direct chemotherapy delivery to the lungs for colorectal cancer metastases
In Vivo Lung Perfusion (IVLP) as an Adjuvant Treatment for Patients With Resectable Pulmonary Metastases of Colorectal Cancers
This study is testing a new way to deliver chemotherapy directly to the lungs during surgery for people with colorectal cancer that has spread there, to see if it can target cancer cells better while causing fewer side effects.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05611034 on ClinicalTrials.gov |
What this trial studies
This study investigates a novel technique called In Vivo Lung Perfusion (IVLP) to deliver chemotherapy directly into the lungs during surgery for patients with colorectal cancer that has spread to the lungs. The goal is to target microscopic cancer cells in the lungs while minimizing side effects on other organs. Participants will receive oxaliplatin through IVLP, and the study aims to assess the safety and determine the appropriate dosage for this method. Close monitoring will be conducted to evaluate any side effects experienced by the participants.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with colorectal carcinoma who have bilateral pulmonary metastases and are 70 years old or younger.
Not a fit: Patients who have previously received more than 1000 mg of oxaliplatin or have significant pulmonary disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with colorectal cancer metastases to the lungs by effectively targeting cancer cells while reducing systemic side effects.
How similar studies have performed: Previous studies using the IVLP technique in patients with sarcoma have shown promise, indicating potential for success in this new application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosis of Colorectal Carcinoma 2. Presence of bilateral pulmonary metastases 3. 3 or more lung lesions in total 4. Age 70 years or less 5. ECOG 0-2 6. Absence of extra-pulmonary disease, except liver metastases suitable to curative treatment. Exclusion Criteria: 1. Patient has previously received more than 1000 mg of oxaliplatin 2. Left Ventricular Ejection Fraction \<50% 3. History of significant pulmonary disease or pneumonitis 4. Pregnant or lactating females 5. Age 71 or older, or less than 18 years 6. Inability to understand the informed consent process 7. Hypersenstivity to oxaliplatin 8. Patients with Heparin-induced thrombocytopenia (HIT) 9. Patients who cannot receive cefazolin or methylprednisolone due to allergy or another reason can be included but will not receive the drug they cannot tolerate 10. Current participation in another therapeutic clinical trial
Where this trial is running
Toronto, Ontario
- University Health Network, Toronto General Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Marcelo K Cypel, MD — University Health Network, Toronto
- Study coordinator: Jennifer K Lister
- Email: jennifer.lister@uhn.ca
- Phone: 416-340-4857
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.