RecruitingPhase 1NCT05611034

In Vivo Lung Perfusion (IVLP) for Colorectal Cancer Metastatic to Lung

In Vivo Lung Perfusion (IVLP) as an Adjuvant Treatment for Patients With Resectable Pulmonary Metastases of Colorectal Cancers


Sponsor

University Health Network, Toronto

Enrollment

10 participants

Start Date

Feb 6, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study is investigating a new technique for delivering chemotherapy directly into the lungs at the time of surgery. Delivering chemotherapy directly to the lungs could potentially kill any microscopic cancer cells that are present in the lungs at the time of surgery, while sparing other major organs in the body from the side effects of chemotherapy. This technique is called In Vivo Lung Perfusion (IVLP). At the University Health Network, this IVLP technique has been used recently in a Phase I study in patients with sarcoma, and we are now expanding on that experience to include patients with colorectal metastases. The purpose of this study is to test the safety of the IVLP technique and find the dose that seems right in humans. Participants are given oxaliplatin into one lung via IVLP and are watched very closely to see what side effects they have and to make sure the side effects are not severe. If the side effects are not severe, then more participants are asked to join the study and are given a higher dose of oxaliplatin. Participants joining the study later on will get higher doses of oxaliplatin than participants who join earlier. This will continue until a dose is found that causes severe but temporary side effects. Doses higher than that will not be given. The other lung will not be infused with anything, so that we can limit unforeseen toxicity to a single lung and see if one lung does better than the other.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a procedure called in vivo lung perfusion (IVLP) — delivering high-dose chemotherapy directly into the lungs while they remain in the body — for people with colorectal cancer that has spread to both lungs. **You may be eligible if...** - You have colorectal cancer with bilateral (both-sided) lung metastases (3 or more lung lesions total) - You are 70 years old or younger - Your heart function is good (ECOG 0–2, ejection fraction ≥ 50%) - Any liver metastases you may have are suitable for curative treatment - You have no cancer spread outside the lungs and liver **You may NOT be eligible if...** - You have previously received more than 1,000 mg of oxaliplatin - You have significant lung disease or a history of serious pneumonia - You are pregnant or breastfeeding - You are older than 70 or younger than 18 - You have other contraindications to the procedure (check with your doctor) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOxaliplatin

Oxaliplatin infusion in single lung via IVLP technique


Locations(1)

University Health Network, Toronto General Hospital

Toronto, Ontario, Canada

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NCT05611034


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