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 pulmonary malignancy. We hypothesize that heterogeneous dose distributions could generate a vaccination effect against the tumor by creating anti-tumoral immune response in the body and these patients may be immunized against their tumor which could reduce the risk of cancer recurrence after transplantation despite the anti-rejection medications required for the transplantation.
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.
Age < 18
Mediastinal nodes metastasis demonstrated on EBUS-TBNA
Distant metastasis demonstrated on PET scan or brain imaging.
Failure to provide informed consent
Sequential
Radiation: Varying Doses of RT
Radiation3+3 radiation dose escalation model to see the maximum tolerated dose
Maximum Tolerated Dose for Radiation
AEs will be graded by CTCAE. Maximum tolerated dose is the dose level do not result in fatal injury (grade 5 lung toxicity) or life-threatening or fatal treatment related toxicity (grade 4+). Safety will be determined by the absence of grade 3 or greater (G3+) complications related to radiation and the feasibility to list patients for transplantation one week after the end of radiation will be determined.
Patient Morbidity
NCI common toxicity scale
Local recurrence
Documented radiographically
Click on the lead sponsor to view all of their trials.
Marc de Perrot
Lead sponsor
University Health Network, Toronto
Sponsor institution
