Double Lung Transplant REgistry Aimed for Lung-limited Malignancies

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.

Inclusion Criteria:Common Inclusion CriteriaAdults of Age ≦ 70 for cohort A, Age ≦60 for cohort BResistant or refractory to or without available standard of care treatment options or experimental treatment options that are known to increase survival outcomePatients without any involvement of mediastinal lymph nodes involvement confirmed by the endobronchial ultrasound (EBUS) or mediastinoscopy (note: involvement of hilar or intrapulmonary lymph nodes are allowed)Patients with good general health with an ability to withstand physiologic stressors and undergo psychosocial evaluation by the Stanford Integrated Psychosocial Assessment for Transplantation (SIPAT) or other assessment toolsInclusion Criteria for Cohort A • Histologically confirmed selected lung adenocarcinoma typesaccording to the International Association for the Study of Lung Cancer (IASLC)/American Thoracic Society (ATS)/European Respiratory Society (ERS) classification- Lepidic dominant patternAdenocarcinoma in situMinimally invasive adenocarcinomaNon mucinous lepidic predominant invasive adenocarcinomabased on 2015 WHO classification of lung tumors includingInvasive mucinous adenocarcinoma• Mixed invasive mucinous and mucinous adenocarcinomaColloid adenocarcinomaEnteric adenocarcinomaMinimally invasive adenocarcinomaNonmucinousMucinousPreinvasive lesionsAtypical adenomatous hyperplasiaAdenocarcinoma in situNonmucinousMucinousbased on the 2004 WHO classification of lung tumors including - Bronchioloalveolar carcinomaNonmucinousMucinousMixed nonmucinous and mucinous or indeterminateWithout any distant metastasis confirmed by standard staging work-upWithout brain metastasis confirmed by brain imagingWithout unidentified primary site of cancerInclusion Criteria for Cohort BMetastatic cancers to lung alone - including but not limited to germ cell tumors, head & neck tumors, colorectal tumors, renal cell tumors, testicular cancerWithout any other distant metastasis confirmed by standard staging work-upExclusion Criteria:Exclusion criteriaAdults unable or unwilling to consentIndividuals who are not yet adults (infants, children, teenagers)Pregnant womenPrisonersVulnerable PopulationsPresence of extrapulmonary disease or mediastinal nodal disease at the time of transplant referralSmall Cell CancersUnidentified primary site of cancer for Cohort AProgression of disease or confirmed distant metastases or mediastinal nodal disease at any point during transplantation work-upMedical ineligibility for lung transplantation after multidisciplinary assessmentNot a suitable candidate according to the lung transplantation protocol for treatment of lung confined primary or metastatic tumorsBody mass index more than 35 kg/m2Evidence of co-existing malignancies for Cohort AUntreatable significant dysfunction of another major organ system including heart, liver, kidney, or brain unless combined organ transplantation can be performedUncorrected atherosclerotic disease with suspected or confirmed end-organ ischemia or dysfunction and/or coronary artery disease not amenable to revascularizationUncorrectable bleeding diathesisEvidence of active Mycobacterium tuberculosis infectionSignificant chest wall or spinal deformity expected to cause severe restriction after transplantation