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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorNorthwestern University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Double Lung Transplantation

    Procedure/Surgery

    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.

Treatment groups

125 Participants
are divided into 3 treatment groups
Group A: Cohort A: Primary lung cancers1 intervention
Group B: Cohort B: Metastatic cancers to the lung only1 intervention
Group C: Cohort C: Respiratory failure with a history of cancer in the last 5 years1 intervention

Trial outcomes

Primary outcomes

1

overall survival (OS) rate

Time frame
30-day
2

overall survival (OS) rate

Time frame
90-day
3

disease-free survival (DFS) rate

Time frame
30-day
4

disease-free survival (DFS) rate

Time frame
90-day

Secondary outcomes

1

overall survival (OS) rate

Time frame
6-month, 1-year, 3-year, and 5-year
2

disease-free survival (DFS) rate

Time frame
6-month, 1-year, 3-year, and 5-year
3

allograft rejection (AR) rate

Time frame
6-month, 1-year, 3-year, and 5-year
4

allograft survival (AS) rate

Time frame
6-month, 1-year, 3-year, and 5-year

Other outcomes

Sponsors and contacts

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