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

NCT ID: NCT05611034

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-06
• Study Completion Date: 2032-01-01

Brief 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.

Conditions

Lung Metastases; Colorectal Cancer Metastatic; Colorectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IVLP in single lung

Group Type: EXPERIMENTAL

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin infusion in single lung via IVLP technique

Interventions

Oxaliplatin

Oxaliplatin infusion in single lung via IVLP technique

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcelo K Cypel, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

University Health Network, Toronto General Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Jennifer K Lister

Role: CONTACT

jennifer.lister@uhn.ca

416-340-4857

Facility Contacts

Jennifer Lister, BSc CCRP

Role: primary

Jennifer.Lister@uhn.ca

416-340-4857

Other Identifiers

20-6152

Identifier Type: -

Identifier Source: org_study_id