Direct chemotherapy delivery to the lungs for colorectal cancer metastases

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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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.