Non-ablative Oligofractionated Radiation Therapy Before Surgical Transplantation As Radiovaccination

Launched by MARC DE PERROT · Mar 1, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with advanced lung disease and lung cancer who are preparing for a lung transplant. The researchers want to find out if using a specific type of radiation therapy called non-ablative oligofractionated radiation therapy (NORT) before the transplant can help the body build an immune response against the cancer. This could potentially lower the chances of the cancer coming back after the transplant, even while patients are taking medications to prevent their bodies from rejecting the new lung.

To be eligible for this trial, participants must be at least 18 years old and have severe lung disease with a suspected early-stage lung cancer that cannot be treated with surgery or other standard treatments. They should also be candidates for a lung transplant, apart from their cancer diagnosis. Participants in the study will undergo the radiation therapy and then be monitored closely to see how well their body responds. It's important for potential participants to understand the risks and benefits of this study and to be able to give informed consent. If you're interested in joining the trial or want more information, please reach out to the research team.

Gender

ALL

Eligibility criteria

• 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.