DREAM: Double Lung Transplant REgistry Aimed for Lung-limited Malignancies (DREAM)

November 12, 2024 updated by: Young Kwang Chae, Northwestern University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Lung Transplant Thoracic Surgery, Canning Thoracic Institute (Northwestern Memorial Hospital)
  • Phone Number: 312-695-5864
  • Email: anne.oboye@nm.org

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Thoracic Surgery, Canning Thoracic Institute (Northwestern Memorial Hospital)
        • Contact:
        • Contact:
          • Lung Transplant Thoracic Surgery, Canning Thoracic Institute (Northwestern Memorial Hospital)
          • Phone Number: 312-695-5864
          • Email: anne.oboye@nm.org
        • Contact:
          • Young Chae, MD MPH MBA
        • Contact:
          • Ankit Bharat, MD
        • Contact:
          • Rade Tomic, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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

Description

Inclusion Criteria:

Any patient who is undergoing double lung transplantation as part of the clinical program, consents for this prospective observational trial, and has one of the following conditions will be eligible.

  • 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
    • 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 tools
    • Patients to meet all other criteria for lung transplantation including insurance approval and United Network for Organ Sharing (UNOS) registration

Inclusion Criteria for Cohort A

  • Histologically confirmed selected lung non-small cell lung cancer including but not limited to:

    o according to the International Association for the Study of Lung Cancer (IASLC)/American Thoracic Society (ATS)/European Respiratory Society (ERS) classification

    - Lepidic dominant pattern

  • Adenocarcinoma in situ
  • Minimally invasive adenocarcinoma

  • Non mucinous lepidic predominant invasive adenocarcinoma

    o based on 2015 World Health Organization (WHO) classification of lung tumors including

    - Invasive mucinous adenocarcinoma

  • Mixed invasive mucinous and mucinous adenocarcinoma

    • Colloid adenocarcinoma
    • Enteric adenocarcinoma
    • Minimally invasive adenocarcinoma
  • Nonmucinous

  • Mucinous

    - Preinvasive lesions

  • Atypical adenomatous hyperplasia

  • Adenocarcinoma in situ

    • Nonmucinous
    • Mucinous
    • based on the 2004 WHO classification of lung tumors including - Bronchioloalveolar carcinoma
  • Nonmucinous
  • Mucinous
  • Mixed nonmucinous and mucinous or indeterminate
  • Without any distant metastasis confirmed by standard staging work-up
  • Without brain metastasis confirmed by brain imaging
  • Without unidentified primary site of cancer

Inclusion Criteria for Cohort B

  • Metastatic cancers to lung alone - including but not limited to germ cell tumors, head & neck tumors, colorectal tumors, renal cell tumors, testicular cancer
  • Without any other distant metastasis confirmed by standard staging work-up

Inclusion Criteria for Cohort C

  • Respiratory failure with a history of cancer in the last 5 years - including, but not limited to interstitial lung disease (ILD), pulmonary fibrosis (idiopathic or secondary), advanced chronic obstructive pulmonary disease (COPD), bronchiectasis, emphysema, cystic fibrosis (CF), emphysema due to alpha-1 antitrypsin deficiency, and pulmonary arterial hypertension (PAH)
  • Without any other distant metastasis confirmed by standard staging work-up

Exclusion Criteria:

  • Exclusion criteria

    • Adults unable or unwilling to consent
    • Individuals who are not yet adults (infants, children, teenagers)
    • Pregnant women
    • Prisoners
    • Vulnerable Populations
    • Presence of extrapulmonary disease or mediastinal nodal disease at the time of transplant referral
    • Small Cell Cancers
    • Unidentified primary site of cancer for Cohort A
    • Progression of disease or confirmed distant metastases or mediastinal nodal disease at any point during transplantation work-up
    • Medical ineligibility for lung transplantation after multidisciplinary assessment
    • Not a suitable candidate according to the lung transplantation protocol for treatment of lung confined primary or metastatic tumors
  • Body mass index more than 35 kg/m2
  • Evidence of co-existing malignancies for Cohort A
  • Untreatable significant dysfunction of another major organ system including heart, liver, kidney, or brain unless combined organ transplantation can be performed
  • Uncorrected atherosclerotic disease with suspected or confirmed end-organ ischemia or dysfunction and/or coronary artery disease not amenable to revascularization
  • Uncorrectable bleeding diathesis
  • Evidence of active Mycobacterium tuberculosis infection
  • Significant chest wall or spinal deformity expected to cause severe restriction after transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort A: Primary lung cancers
- Examples include invasive mucinous/non-mucinous non-small cell lung cancers and multifocal carcinomas
Procedure: Double Lung Transplantation
To 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.
Other Names:
  • Lung Transplantation
Cohort B: Metastatic cancers to the lung only
- Examples include germ cell tumors, head & neck tumors, colorectal tumors, renal cell tumors
Procedure: Double Lung Transplantation
To 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.
Other Names:
  • Lung Transplantation
Cohort C: Respiratory failure with a history of cancer in the last 5 years
- Examples include, but not limited to interstitial lung disease (ILD), pulmonary fibrosis (idiopathic or secondary), advanced chronic obstructive pulmonary disease (COPD), bronchiectasis, emphysema, cystic fibrosis (CF), emphysema due to alpha-1 antitrypsin deficiency, and pulmonary arterial hypertension (PAH)
Procedure: Double Lung Transplantation
To 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.
Other Names:
  • Lung Transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival (OS) rate
Time Frame: 30-day
30-day
overall survival (OS) rate
Time Frame: 90-day
90-day
disease-free survival (DFS) rate
Time Frame: 30-day
30-day
disease-free survival (DFS) rate
Time Frame: 90-day
90-day
allograft rejection (AR) rate
Time Frame: 30-day
30-day
allograft rejection (AR) rate
Time Frame: 90-day
90-day
allograft survival (AS) rate
Time Frame: 30-day
30-day
allograft survival (AS) rate
Time Frame: 90-day
90-day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival (OS) rate
Time Frame: 6-month, 1-year, 3-year, and 5-year
6-month, 1-year, 3-year, and 5-year
disease-free survival (DFS) rate
Time Frame: 6-month, 1-year, 3-year, and 5-year
6-month, 1-year, 3-year, and 5-year
allograft rejection (AR) rate
Time Frame: 6-month, 1-year, 3-year, and 5-year
6-month, 1-year, 3-year, and 5-year
allograft survival (AS) rate
Time Frame: 6-month, 1-year, 3-year, and 5-year
6-month, 1-year, 3-year, and 5-year
Major post-transplantation morbidity (MPTM)
Time Frame: 6-month, 1-year, 3-year, and 5-year
including acute kidney failure requiring continuous renal replacement therapy
6-month, 1-year, 3-year, and 5-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Young Chae, MD MPH MBA, Northwestern University
  • Principal Investigator: Ankit Bharat, MD, Northwestern University
  • Principal Investigator: Rade Tomic, MD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2022

Primary Completion (Estimated)

November 1, 2032

Study Completion (Estimated)

November 1, 2032

Study Registration Dates

First Submitted

December 19, 2022

First Submitted That Met QC Criteria

January 3, 2023

First Posted (Actual)

January 5, 2023

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

November 12, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00217958
  • NU 22L02 (Other Identifier: Northwestern university)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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