Non-ablative Oligofractionated Radiation Therapy Before Surgical Transplantation As Radiovaccination
Recruiting · NCT04782752 · Interventional (participants receive a specific treatment) · Lead sponsor: Marc de Perrot
View the official record on ClinicalTrials.gov →Interventions studied
Radiation: Varying Doses of RT
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- Toronto General Hospital, University Health Network - Toronto, Ontario, Canada