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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 years later Aug 1, 2026 → Aug 1, 2031
See other at-risk trials from University Health Network, Toronto

Record History

  1. Primary completion pushed from Aug 1, 2026 to Aug 1, 2031 Eligibility criteria expanded, about 16 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 16 words
  2. Primary completion date: Jan 1, 2026 to Aug 1, 2026v5
  3. Primary completion date: Jan 1, 2027 to Jan 1, 2026v4
  4. Re-verified, no change to tracked fieldsv3
  5. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Oct 31, 2022 to Feb 6, 2023 · Study sites: 0 to 1v2 Show 2 more changesShow less
    • Start date changed from estimate of Oct 31, 2022 to Feb 6, 2023
    • Study sites: 0 to 1
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05611034
Lead Sponsor University Health Network, Toronto
Conditions Lung Metastases, Colorectal Cancer Metastatic, Colorectal Cancer
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov