DREAM: Double Lung Transplant REgistry Aimed for Lung-limited Malignancies — DREAM  

Lung Cancer Clinical Trial

Official title: Double Lung Transplant REgistry Aimed for Lung-limited Malignancies (DREAM) - a Prospective Observational Registry Study for Patients Undergoing Lung Transplantation for Medically Refractory Cancers Confined to the Lungs

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

Ever since human lung transplantation was first performed in a patient with advanced lung cancer in 1963 [1], it has emerged as a well-established treatment for patients suffering from a variety of end-stage pulmonary diseases. While lung transplant continues to be performed for refractory lung-limited malignancies that do not have extrapulmonary disease [2-6], given the perceived risks of tumor recurrence following transplantation and potentially reduced survival compared to patients with chronic end-stage lung diseases, transplants for cancer constitutes less than 0.5% of all such procedures (www.srtr.org). The need for lung transplantation is not only confined to patients with primary lung cancers. There are unmet needs for patients who have lung-limited metastasis after successful treatment for primary tumors such as sarcomas or colorectal cancer (CRC). Indeed, successful reports of lung transplantation for lung only metastasis that are refractory to standard of care treatment has been demonstrated [3] and proposed by international experts in highly selected patients [6]. Solid organ transplantation for both primary and metastatic cancers has been demonstrated in liver transplantation [7, 8]. While uncommonly performed, for patients with refractory lung cancer or those with concomitant respiratory failure, lung transplantation may be the only treatment option. The 5-year overall survival of patients in some prior reports who underwent double lung transplantation (DLT) for lung cancer was 39-57%[2, 9], compared to those with non-malignant diseases 50-59%[10, 11]. Indeed, lung transplants have been steadily increasing for cancers, as evident in the International Society of Lung Transplantation (ISHLT) [4-6]. However, the reported cases represent heterogeneity in the surgical technique, patient selection, and post-operative management.

This prospective observational registry aims to better understand the long-term outcomes in patients undergoing double lung transplantation for lung-limited cancers in the clinical programs at Northwestern Medicine and participating centers. We aim to study the impact of a standardized approach to patient selection, tumor staging, surgical technique, and post-operative management on the long-term survival following lung transplantation in patients with lung-limited malignancy. Specifically, this study aims to investigate the clinical outcomes of patients who undergo lung transplantation for treatment of a select group of medically refractory cancers affecting the lungs without extrapulmonary metastases. Patients will undergo transplantation if they have failed standard of care treatments and do not have further curative treatment/trials options. Their clinical courses including overall survival, disease-free survival, and graft failure will be monitored as well as the molecular and genetic biomarkers to investigate the correlation with the prognosis. ;

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Lung Transplant

• NCT number: NCT05671887
• Study type: Observational [Patient Registry]
• Source: Northwestern University
• Contact: Lung Transplant Thoracic Surgery, Canning Thoracic Institute (No
• Phone: 312-695-5864
• Email: anne.oboye@nm.org
• Status: Recruiting
• Start date: November 16, 2022
• Completion date: November 2032