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

NCT05611034 | Recruiting Phase 1

• 1 other identifier: 20-6152
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Metastases; Colorectal Cancer; Colorectal Cancer Metastatic

Keywords

IVLP; metastatic

Outcome Measures

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).

  72 hours

Secondary Outcomes (4)

• recurrence patterns

  5 years

• Incidence of pneumonia after procedure

  72 hours

• Incidence of ICU admission

  72 hours

• Incidence of mechanical ventilation

  72 hours

Study Arms (1)

IVLP in single lung

EXPERIMENTAL

Drug: Oxaliplatin

Interventions

Oxaliplatin DRUG

Oxaliplatin infusion in single lung via IVLP technique

IVLP in single lung

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Colorectal Carcinoma
• Presence of bilateral pulmonary metastases
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network, Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Interventions

Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Marcelo K Cypel, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer K Lister

CONTACT

416-340-4857; jennifer.lister@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 9, 2022
• Study Start: February 6, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): January 1, 2032
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)