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New treatment option for Transplant-Related Lung Cancer
Official title Non-ablative Oligofractionated Radiation Therapy Before Surgical Transplantation As Radiovaccination
ClinicalTrials.gov ID: NCT04782752
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Patients with multifocal pulmonary malignancy, including multifocal lung adenocarcinoma, not accessible to curative treatment, including surgery and...
- Patients with isolated metastases in one or both lungs after complete resection of the primary tumor in the absence of other sites of metastatic...
- Meet eligibility criteria for lung transplantation with the exception of the underlying malignancy.
You likely can't join if
- 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...
See the full eligibility 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...
- Meet eligibility criteria for lung transplantation with the exception of the underlying malignancy.
- people 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 \< 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.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.