About this trial
This is a prospective observational registration trial for patients who undergo lung transplantation for the treatment of the select groups of medically refractory cancers affecting the lungs alone without extrapulmonary nodal and distant metastasis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Common Inclusion Criteria
Adults of Age ≦ 80
Resistant or refractory to or without available standard of care treatment options or experimental treatment options that are known to increase survival outcome
Patients without any extrapulmonary disease
Disqualifiers
Exclusion criteria
Adults unable or unwilling to consent
Individuals who are not yet adults (infants, children, teenagers)
Pregnant women
Trial population
This is a prospective observational registration trial for patients who undergo lung transplantation using cadaveric organs for medically refractory cancers affecting the lungs alone and without extrapulmonary metastasis after meeting the inclusion criteria of the clinical program at Northwestern Medicine and participating centers. Essential Clinical Criteria: 1. The tumor should be without any extrapulmonary metastasis as determined by standard of care diagnostic and staging workup. 2. All standard of care or experimental oncological treatments known to improve survival should have failed or deemed infeasible 3. Patients should meet the general criteria for lung transplant evaluation and listing
Trial design
Cohort
Prospective
Treatments tested in this trial
Double Lung Transplantation
Procedure/SurgeryTo evaluate outcomes among patients who undergo lung transplantation for treatment of a select group of medically refractory cancers affecting the lungs alone without extrapulmonary nodal and distant metastasis.
Treatment groups
Trial outcomes
Primary outcomes
overall survival (OS) rate
overall survival (OS) rate
disease-free survival (DFS) rate
disease-free survival (DFS) rate
Secondary outcomes
overall survival (OS) rate
disease-free survival (DFS) rate
allograft rejection (AR) rate
allograft survival (AS) rate
Sponsors and contacts
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