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NCT Number: NCT05611034

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

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.

Recruiting

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Key information

Conditions

Lung Metastases Colonic Diseases Colorectal Cancer Colorectal Cancer Metastatic Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Health Network, Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location status: Recruiting

Location contact

Jennifer Lister, BSc CCRP

CONTACT

[email protected]

416-340-4857

Marcelo Cypel, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxaliplatin

Drug

Oxaliplatin infusion in single lung via IVLP technique

Primary outcomes

  1. 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).

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer K Lister

CONTACT

[email protected]

416-340-4857

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2032
First posted
Nov 9, 2022
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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