Recruiting

Radiovaccination

Sponsor:

Marc de Perrot

Code:

NCT04782752

Conditions

Transplant-Related Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Radiation: Varying Doses of RT

Study Details

Brief summary:

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

Transplant-Related Lung Cancer

Study ID

NCT04782752

Start date

Apr 28, 2021

Status verified date

Jan, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental: Radiation

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.

Interventions

Radiation: Varying Doses of RT

3+3 radiation dose escalation model to see the maximum tolerated dose

Primary outcome measure

  • Maximum Tolerated Dose for Radiation [ Time Frame: Up to four years ]

Central Contacts and Locations

Central contacts

Marc de Perrot, MD, MSc

416 340-5549marc.deperrot@uhn.ca

John Cho, MD, PhD

416-946-4501John.Cho@rmp.uhn.ca

Locations

Toronto General Hospital, University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Marc de Perrot, MD, MSc

416 340-5549Marc.dePerrot@uhn.ca

Fatemeh Zaeimi, MSc

416-340-5686Fatemeh.Zaeimi@uhn.ca

More Information

Sponsor

Marc de Perrot

Last update posted

Feb 4, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Marc de Perrot on 2025-02-04.