Clinical trial · Interventional
Non-ablative Oligofractionated Radiation Therapy Before Surgical Transplantation As Radiovaccination
NCT04782752CI-TRIAL-00085457NORThSTARrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260911-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Transplant-Related Lung Cancer | Transplant-Related Lung Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation: Varying Doses of RT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: Radiation
- description
- Patients will be differentiated into 4 groups: 1. Patients with end-stage interstitial lung disease (ILD) and suspected stage I (up to 4 cm) primary lung cancer 2. Patients with end-stage lung disease other than ILD (e.g. emphysema/COPD, cystic fibrosis and pulmonary hypertension) and suspected stage I (up to 4 cm) primary lung cancer 3. Patients with multifocal primary lung cancer (e.g. multifocal adenocarcinoma) in the absence of nodal metastasis and distant metastasis. 4. Patients with isolated pulmonary metastasis in the absence of other sites of malignancy (primary and metastatic). For this study, different doses will be used for each different group depending on their tumour size. The first 3 patients will start with a dose of 4 Gy, for the ILD group, or 8 Gy, for the non ILD group. The doses are then increased incrementally until the dose limiting toxicity is reached.
- interventionNames
- Radiation: Radiation: Varying Doses of RT
Primary outcomes (1)
- measure
- Maximum Tolerated Dose for Radiation
- timeFrame
- Up to four years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.