Recruiting
Phase 1

In Vivo Lung Perfusion

Sponsor:

University Health Network, Toronto

Code:

NCT05611034

Conditions

Lung Metastases

Colorectal Cancer Metastatic

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Oxaliplatin

Study Details

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 ID

NCT05611034

Start date

Feb 6, 2023

Status verified date

Apr, 2026

Completion date

Jan 1, 2032

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: IVLP in single lung

Interventions

Oxaliplatin

Oxaliplatin infusion in single lung via IVLP technique

Primary outcome measure

  • safety as measured by acute lung injury findings [ Time Frame: 72 hours ]

Central Contacts and Locations

Central contacts

Locations

University Health Network, Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Jennifer Lister, BSc CCRP

416-340-4857Jennifer.Lister@uhn.ca

Principal Investigator:

Marcelo Cypel, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Keywords

  • IVLP
  • metastatic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-04-29.