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RecruitingNCT05611034Updated Sep 29, 2026

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

A Phase 1 interventional study of Oxaliplatin in Lung Metastases, Colorectal Cancer Metastatic and Colorectal Cancer, sponsored by University Health Network, Toronto. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by University Health Network, Toronto · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Lung Metastases
  • Colorectal Cancer Metastatic
  • Colorectal Cancer

Keywords

  • IVLP
  • metastatic
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    IVLP in single lung

    Drug: Oxaliplatin

Interventions

  • DrugOxaliplatin

    Oxaliplatin infusion in single lung via IVLP technique

05

What researchers measure

Primary outcomes

  1. safety as measured by acute lung injury findings

    Chest x- ray findings of pulmonary edema in the perfused lung in the first 72 hours (Grade 0-5).

    Time frame: 72 hours

Secondary outcomes

  1. recurrence patterns

    Time frame: 5 years

  2. Incidence of pneumonia after procedure

    Time frame: 72 hours

  3. Incidence of ICU admission

    Time frame: 72 hours

  4. Incidence of mechanical ventilation

    Time frame: 72 hours

06

Study locations

1 of 1 sites recruiting
  • University Health Network, Toronto General Hospital
    Toronto, Ontario M5G 2C4, Canada
    • Jennifer Lister, BSc CCRP · Contact · Jennifer.Lister@uhn.ca · 416-340-4857
    • Marcelo Cypel, MD · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05611034
Lead sponsor
University Health Network, Toronto
Responsible party
Sponsor
First posted
Nov 9, 2022
Start date
Feb 6, 2023
Primary completion
Aug 1, 2031 (estimated)
Completion
Jan 1, 2032 (estimated)
Last update
Sep 29, 2026

Study contacts

Jennifer K Lister
Contact
jennifer.lister@uhn.ca
416-340-4857
Marcelo K Cypel, MD
principal investigator · University Health Network, Toronto

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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