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Recruiting NCT05611034

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

Phase I Interventional Lung Metastases Colorectal Cancer Metastatic Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oxaliplatin.
Who it may be relevant to
Registry conditions: Lung Metastases, Colorectal Cancer Metastatic, Colorectal Cancer. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

In Vivo Lung Perfusion (IVLP) as an Adjuvant Treatment for Patients With Resectable Pulmonary Metastases of Colorectal Cancers

Overview

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.

Interventions

  • Drug Oxaliplatin
    Oxaliplatin infusion in single lung via IVLP technique

Primary outcome measures

  • safety as measured by acute lung injury findings [Time frame: 72 hours]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • University Health Network, Toronto General Hospital — Toronto

Identifiers

NCT: NCT05611034 · 20-6152

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗