Program Status
RecruitingPhase
Phase 1Prior Immunotherapy Allowed
YesCRC-directed Trial
YesDrugs
oxaliplatinTags
MSI-H/ MMRd, MSS/ MMRpComments
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
Helpful Links
https://pubmed.ncbi.nlm.nih.gov/24290703/ https://www.sciencedirect.com/science/article/pii/S0022522320306358Location | Location Status |
---|---|
Canada | |
University Health Network, Toronto General Hospital Toronto, Ontario M5G 2C4 |
Recruiting |
Contacts
Inclusion Criteria
Inclusion Criteria:
1. Diagnosis of Colorectal Carcinoma
2. Presence of bilateral pulmonary metastases
3. 3 or more lung lesions in total
4. Age 70 years or less
5. ECOG 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. Left Ventricular Ejection Fraction <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 informed consent 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