ClinicalTrials.gg
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

From the registry’s dates

  • Started Feb 2023; still recruiting 3 years 9 months later.
Updated Sep 29, 2026Primary completion movedGo to Updates ↓

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

Where this study stands

Counted across the records on this site · 2026-11-14

Among 206 studies testing oxaliplatin in Colorectal Neoplasms — 21 open to participants now, 25 under way, 6 of them phase 3. Oxaliplatin · Colorectal Neoplasms.

Planned enrollment
160th of 183
10 · median 50
Started
2023
with 4 others
Phase 1
29 of 206
4 open now
Primary completion
2031-08
later than 23 of 24 live
Registered
191st of 206
by date

Among the 206 studies testing oxaliplatin in Colorectal Neoplasms, this one is the 160th largest by planned enrollment of the 183 interventional ones that give a count, is one of 5 that started in 2023, is one of 29 in phase 1, reaches primary completion later than 23 of the 24 other live ones, and was the 191st registered.

Colorectal Neoplasms

6,545 studies on the registry are indexed under Colorectal Neoplasms; 1,664 are open to participants now.

Browse Colorectal Neoplasms studies →

Open to participants now

21 of the 206 studies testing oxaliplatin in Colorectal Neoplasms are open now, in 12 countries. Recruiting first, the newest first:

15 more — sign in →

By country, each count listing its studies:

All 21 open studies →

About oxaliplatin

Oxaliplatin: first FDA approval 2002 (ELOXATIN). What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 1,181 Colorectal Neoplasms studies recruiting now, 764 (65%) set no upper age limit and 264 (22%) stop at 75 or younger; 48 take children under 18; 123 take healthy volunteers.

This study: 18 Years to 70 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 206 studies testing oxaliplatin in Colorectal Neoplasms, or all of them as a file.
02

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.

03

Conditions studied

  • Lung Metastases
  • Colorectal Cancer Metastatic
  • Colorectal Cancer

Keywords

  • IVLP
  • metastatic
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Diagnosis of Colorectal Carcinoma
  2. Presence of bilateral pulmonary
  3. 3 or more lung lesions in total
  4. Age 70 years or less
  5. 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. \<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 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

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

  • Oxaliplatin infusion in single lung via IVLP technique

06

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2023 (actual). Primary completion is estimated for Aug 2031, 101 months after the start.

Of 166 non-industry phase 1 interventional studies under Colorectal Neoplasms, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 74. This study's planned 101 months is above that.

Counting every sponsor, half of 434 studies reached it within 48 months; a quarter within 31 and three quarters within 69.

Primary completion moved once since we started tracking on Sep 25, 2026: Aug 2026 → Aug 2031, on Sep 29, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Oct 27, 2022
First posted
Nov 9, 2022
StartActual
Feb 6, 2023
Primary completionEst.
Aug 1, 2031was Aug 2026
CompletionEst.
Jan 1, 2032
Last update
Sep 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Aug 1, 2026→Aug 1, 2031
Sep 29, 2026
Show all 1 update
  1. Sep 29, 2026
    Primary completion Aug 1, 2026→Aug 1, 2031
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05611034
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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Discussion

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Studies of the drug tested here: Oxaliplatin

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