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

Estado del programa

Reclutamiento

Fase

Fase 1

Inmunoterapia previa permitida

Ensayo dirigido por el CRC

Drogas

oxaliplatin

Etiquetas

MSI-H/ MMRd, MSS/ MMRp

Comentarios

Trial in Canada for patients with metastatic colon or rectal cancer with bilateral pulmonary metastases (presence of mets in both lungs). The trial explores a novel technique that allows the delivery of chemotherapy directly to the lesions.

In Vivo Lung Perfusion (IVLP): delivery of chemotherapy directly to the lungs at the time of surgery; it could potentially kill any microscopic cancer cells that are present in the lungs while sparing other major organs in the body from the side effects of chemotherapy.

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. 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.

Principal Investigator: Dr. Marcelo Cypel

Ubicación Situación
Canadá
University Health Network, Toronto General Hospital
Toronto, Ontario M5G 2C4
Reclutamiento

Contactos

Jennifer K Lister
Póngase en contacto con
416-340-4857 jennifer.lister@uhn.ca

Criterios de inclusión

Criterios de inclusión:

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.

Criterios de exclusión

Criterios de exclusión:

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

NCT ID

NCT05611034

Fecha en que se añadió el juicio

2022-11-09

Fecha de actualización

2024-04-12