NCT04782752Recruiting
Non-ablative Oligofractionated Radiation Therapy Before Surgical Transplantation As Radiovaccination
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 1 Mar 2021
- Start date
- 28 Apr 2021
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Marc de Perrot
- Diseases
- Lung cancer
- NCT number
- NCT04782752
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 28 Apr 2021 to the primary completion date, 30 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous thoracic radiation resulting in significant mediastinal or chest wall overlap precluding re-irradiation
Other illness
- Failure to provide informed consent
- Any other medical condition that, in the opinion of the multidisciplinary team, may interfere with the subject's participation or compliance with the treatment.
Age
- Age \< 18
Other
- Mediastinal nodes metastasis demonstrated on EBUS-TBNA
- Distant metastasis demonstrated on PET scan or brain imaging.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Toronto General Hospital, University Health Network Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.