Status:
RECRUITING
Non-ablative Oligofractionated Radiation Therapy Before Surgical Transplantation As Radiovaccination
Lead Sponsor:
Marc de Perrot
Conditions:
Transplant-Related Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a prospective phase I study to determine the safety and feasibility of non-ablative oligofractionated radiation therapy (NORT) before lung transplantation for patients with underlying pulmonar...
Detailed Description
This study is designed to deliver short courses of radiation to the pulmonary malignancy followed by resection of the radiated tumor at the time of transplant. The study is a 3+3 phase 1 study with i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04782752
Start Date
April 28 2021
End Date
December 1 2025
Last Update
February 4 2025
Active Locations (1)
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1
Toronto General Hospital, University Health Network
Toronto, Ontario, Canada, M5G 2C4