Using radiation therapy before lung transplantation to boost immune response against cancer
Non-ablative Oligofractionated Radiation Therapy Before Surgical Transplantation As Radiovaccination
This study is testing if giving a specific type of radiation therapy before lung transplantation can help patients with lung cancer have a better immune response and safely undergo the surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04782752 on ClinicalTrials.gov |
What this trial studies
This prospective phase I study aims to evaluate the safety and feasibility of non-ablative oligofractionated radiation therapy (NORT) prior to lung transplantation in patients with transplant-related lung cancer. The approach involves delivering short courses of radiation to the tumor, followed by surgical resection during transplantation. The study will determine the maximum tolerated dose (MTD) of radiation while monitoring for dose-limiting toxicities. Patients will be stratified based on their underlying lung disease to ensure safety and efficacy.
Who should consider this trial
Good fit: Ideal candidates include adults with end-stage lung disease and suspected stage I primary lung cancer who are not eligible for curative treatments.
Not a fit: Patients with distant metastasis or mediastinal node involvement will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the immune response against cancer, potentially reducing the risk of recurrence after lung transplantation.
How similar studies have performed: While this approach is novel, similar studies exploring radiation therapy as a means to enhance immune response have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 * Patients with end-stage lung disease and suspected stage I primary lung cancer based on CT and PET scan not accessible to curative treatment, including surgery and ablative SBRT. * Patients with multifocal pulmonary malignancy, including multifocal lung adenocarcinoma, not accessible to curative treatment, including surgery and ablative SBRT. * Patients with isolated metastases in one or both lungs after complete resection of the primary tumor in the absence of other sites of metastatic disease, not accessible to curative treatment, including surgery and ablative SBRT. * Meet eligibility criteria for lung transplantation with the exception of the underlying malignancy. * Subjects must be able to understand the potential risks and benefits of the study and must be able to read and provide written, informed consent for the study. Exclusion Criteria: * Age \< 18 * Mediastinal nodes metastasis demonstrated on EBUS-TBNA * Distant metastasis demonstrated on PET scan or brain imaging. * Failure to provide informed consent * Previous thoracic radiation resulting in significant mediastinal or chest wall overlap precluding re-irradiation * Any other medical condition that, in the opinion of the multidisciplinary team, may interfere with the subject's participation or compliance with the treatment.
Where this trial is running
Toronto, Ontario
- Toronto General Hospital, University Health Network — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Marc de Perrot, MD, MSc
- Email: marc.deperrot@uhn.ca
- Phone: 416 340-5549
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.