Recruiting nowPhase 1
What this trial is trying to do
The researchers are testing whether oxaliplatin can be circulated directly through one lung during surgery using in vivo lung perfusion (IVLP), a technique intended to expose lung tissue to chemotherapy while limiting exposure to the rest of the body. The idea is that this could treat microscopic cancer cells left in the lung after visible metastases are removed.
Compared with giving chemotherapy through the bloodstream, direct lung delivery might reduce effects on other organs, but this phase 1 trial is measuring safety—especially acute lung injury—and finding a dose, not whether patients live longer or remain free of cancer for longer.
Worth knowing: This is a small, non-randomised, dose-escalation study with no comparison group, so it cannot establish that IVLP prevents recurrence or improves survival.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT05611034 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 1 |
| Design | not randomised, open label |
| Taking part | 10 people (planned) |
| Who can join | aged 18 Years to 70 Years |
| Run by | University Health Network, Toronto |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Oxaliplatin
What it is measuring
safety as measured by acute lung injury findings
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 1. Tests safety and dose in a small group. Some people do benefit, but that is not what the trial is designed to find out.
How the researchers describe it
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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: Canada.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT05611034, registered by University Health Network, Toronto on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.