NCT05611034RecruitingPhase 1
In Vivo Lung Perfusion (IVLP) for Colorectal Cancer Metastatic to Lung
In Vivo Lung Perfusion (IVLP) as an Adjuvant Treatment for Patients With Resectable Pulmonary Metastases of Colorectal Cancers
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 27 Oct 2022
- Start date
- 6 Feb 2023
- Primary completion date
- 1 Aug 2031
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Lung cancer, Colorectal cancer
- NCT number
- NCT05611034
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 10
- From 6 Feb 2023 to the primary completion date, 1 Aug 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient has previously received more than 1000 mg of oxaliplatin
Other illness
- History of significant pulmonary disease or pneumonitis
- 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
Lab values
- Left Ventricular Ejection Fraction \<50%
Age
- Age 71 or older, or less than 18 years
Other
- Pregnant or lactating females
- Inability to understand the informed consent process
- Hypersenstivity to oxaliplatin
- Patients with Heparin-induced thrombocytopenia (HIT)
- Current participation in another therapeutic clinical trial
Who the study is looking for
- Diagnosis of Colorectal Carcinoma
- Presence of bilateral pulmonary metastases
- 3 or more lung lesions in total
- Age 70 years or less
- ECOG 0-2
- Absence of extra-pulmonary disease, except liver metastases suitable to curative treatment.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Health Network, Toronto General Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.