Lung MetastasesPhase 1NCT05611034
In Vivo Lung Perfusion (IVLP) for Colorectal Cancer Metastatic to Lung
A Phase 1 study testing Oxaliplatin in people with Lung Metastases and Colorectal Cancer Metastatic, run by University Health Network, Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Metastases, Colorectal Cancer Metastatic, Colorectal Cancer
- What is being tested?
- Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 6 Feb 2023to 1 Jan 2032
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patient has previously received more than 1000 mg of oxaliplatin
- Left Ventricular Ejection Fraction <50%
- History of significant pulmonary disease or pneumonitis
- Pregnant or lactating females
- Age 71 or older, or less than 18 years
- Inability to understand the informed consent process
Show all 10Show fewer
- Hypersenstivity to oxaliplatin
- Patients with Heparin-induced thrombocytopenia (HIT)
- 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
- Current participation in another therapeutic clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University Health Network, Toronto General Hospital
Toronto, Ontario, M5G 2C4
Jennifer Lister, BSc CCRP, 416-340-4857, Jennifer.Lister@uhn.ca
Marcelo Cypel, MD
About this study
Official title: In Vivo Lung Perfusion (IVLP) as an Adjuvant Treatment for Patients With Resectable Pulmonary Metastases of Colorectal Cancers
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.
- Being tested
- Oxaliplatin
- Keywords
- IVLP, metastatic
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
Oxaliplatin infusion in single lung via IVLP technique
| Study group | Role | What they receive |
|---|---|---|
| IVLP in single lung | Experimental | Not described Receives: Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 72 hours
Secondary outcomes (4)
recurrence patterns
Measured: 5 years
Incidence of pneumonia after procedure
Measured: 72 hours
Incidence of ICU admission
Measured: 72 hours
Incidence of mechanical ventilation
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start6 Feb 2023
- Primary completion1 Aug 2031 (estimated)
- Study completion1 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung MetastasesStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcelo K Cypel, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611034
- Sponsor's protocol ID
- 20-6152
- Status last verified
- Sep 2026
- First submitted
- 27 Oct 2022
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Lung Perfusion (IVLP) as an Adjuvant Treatment for Patients With Resectable Pulmonary Metastases of Colorectal Cancers
- ClinicalTrials.gov ID
- NCT05611034
- Acronym / sponsor ID
- 20-6152
- Keywords
- IVLP, metastatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 1 Aug 2031 (estimated)
- Study completion
- 1 Jan 2032 (estimated)
- First posted
- 9 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IVLP in single lung | Experimental | Drug: Oxaliplatin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of Colorectal Carcinoma
- Presence of bilateral pulmonary metastases
- 3 or more lung lesions in total
- Age 70 years or less
- ECOG 0-2
Key exclusion criteria (10 listed)
- Patient has previously received more than 1000 mg of oxaliplatin
- Left Ventricular Ejection Fraction <50%
- History of significant pulmonary disease or pneumonitis
- Pregnant or lactating females
- Age 71 or older, or less than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxaliplatinOxaliplatin infusion in single lung via IVLP technique | Drug | IVLP in single lung |
Primary outcome
safety as measured by acute lung injury findings
Time frame: 72 hours
Chest x- ray findings of pulmonary edema in the perfused lung in the first 72 hours (Grade 0-5).
4 secondary outcomes
recurrence patterns
Time frame: 5 years
Incidence of pneumonia after procedure
Time frame: 72 hours
Incidence of ICU admission
Time frame: 72 hours
Incidence of mechanical ventilation
Time frame: 72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Lung Metastases
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marcelo K Cypel, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxaliplatin in people with Lung Metastases and Colorectal Cancer Metastatic, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer K Lister (416-340-4857, jennifer.lister@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety as measured by acute lung injury findings (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.