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

RecruitingPhase 1Ages 18 Years - 70 YearsAllUniversity Health Network, Toronto
NCT05611034 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 ar

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📋 Eligibility rules (as published)
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
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What it tests

  • Oxaliplatin
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Where

1 site
University Health Network, Toronto General Hospital
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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