Transplant-Related Lung Cancer Clinical Trial
— NORTh STAROfficial title:
Non-ablative Oligofractionated Radiation Therapy Before Surgical Transplantation As Radiovaccination
NCT number | NCT04782752 |
Other study ID # | 20-5902 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 28, 2021 |
Est. completion date | December 2025 |
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 | Recruiting |
Enrollment | 42 |
Est. completion date | December 2025 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Toronto General Hospital, University Health Network | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum Tolerated Dose for Radiation | 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. |
Up to four years | |
Secondary | Patient Morbidity | NCI common toxicity scale | Up to four years | |
Secondary | Local recurrence | Documented radiographically | Up to four years |