Non-ablative Oligofractionated Radiation Therapy Before Surgical Transplantation As Radiovaccination

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMarc de Perrot

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Age < 18

Mediastinal nodes metastasis demonstrated on EBUS-TBNA

Distant metastasis demonstrated on PET scan or brain imaging.

Failure to provide informed consent

Trial design

Treatments tested in this trial

  • Radiation: Varying Doses of RT

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

Marc de Perrot

Lead sponsor

University Health Network, Toronto

Sponsor institution