Treatment of Multifocal Lung Adenocarcinoma
Primary Purpose
Lung Neoplasms, Carcinoma Non-small-cell Lung, Adenocarcinoma
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multifocal Lung Adenocarcinoma
Sponsored by

About this trial
This is an interventional treatment trial for Lung Neoplasms focused on measuring multifocal, genetic, bronchoalveolar carcinoma, adenocarcinoma in situ, ground glass opacity, next generation sequencing
Eligibility Criteria
- Patient must be > 18 years of age
- Two or more GGO's or solid lesions suspicious for multifocal disease.
- Clinical diagnosis of N0
- No evidence of distant metastases
- No prior intra-thoracic radiation therapy (NOTE: Previous radiotherapy as part of treatment for head and neck, breast, or other non-thoracic cancer is permitted.), previous chemotherapy, or surgical resection for non-small cell lung cancer (NSCLC).
- No other cancer in the past 5 years except early stage prostate cancer, or basal cell of skin.
- PFT's that show patient is capable of tolerating a lung resection.
- Non-pregnant and non-lactating. Women of child-bearing potential must have a negative urine or serum pregnancy test to participate in the study.
- Patient must be able to understand and willing to sign an IRB-approved informed consent document.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Multifocal Lung Adenocarcinoma
Arm Description
Outcomes
Primary Outcome Measures
Overall Survival
Overall survival compared to survival for Stage IV NSCLC on NCCTG trials
Secondary Outcome Measures
Progressive free survival
Progressive free survival
Treatment Morbidity and Mortality
Treatment Morbidity and Mortality
Post-treatment Pulmonary Function
Post-treatment Pulmonary Function measured by pulmonary function testing (spirometry)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01946100
Brief Title
Treatment of Multifocal Lung Adenocarcinoma
Official Title
A Clinical Pathway for the Treatment of Multifocal Lung Adenocarcinoma Using Genome Sequencing
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To gather preliminary safety and outcome data for the multimodality treatment of lung adenocarcinoma in the setting of multifocal BAC.
Detailed Description
Lung bronchoalveolar carcinoma (BAC) or adenocarcinoma in situ (AIS) continues to represent a poorly understood clinical entity. A frequent clinical dilemma in lung cancer care is the management of a documented or suspected invasive adenocarcinoma in the setting of multifocal ground glass opacity (GGO) consistent with multifocal AIS. These patients are typically classified as stage IV disease, and treated with palliative chemotherapy. No existing pathologic or molecular test is currently capable of making the distinction between independent primary versus metastatic tumors, a distinction for which substantial treatment impact exists. Many treating physicians suspect that outcomes for this specific patient subgroup are better than norms for stage IV disease, as such patients are frequently node-negative and without distant metastases despite multiple lesions present. To address this issue, we will evaluate a multimodality treatment protocol using aggressive local and targeted systemic therapy for multifocal lung adenocarcinoma, incorporating information from tumor genome sequencing for individualized treatment planning. The results will have significant impact in advancing the biologic understanding and treatment approach for lung adenocarcinoma in the setting of multifocal AIS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms, Carcinoma Non-small-cell Lung, Adenocarcinoma
Keywords
multifocal, genetic, bronchoalveolar carcinoma, adenocarcinoma in situ, ground glass opacity, next generation sequencing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Multifocal Lung Adenocarcinoma
Arm Type
Other
Intervention Type
Genetic
Intervention Name(s)
Multifocal Lung Adenocarcinoma
Intervention Description
Tissue collection at the time of surgery for genetic testing and blood sample for germ line DNA.
Primary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival compared to survival for Stage IV NSCLC on NCCTG trials
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Progressive free survival
Description
Progressive free survival
Time Frame
Every 3 months for 2 years
Title
Treatment Morbidity and Mortality
Description
Treatment Morbidity and Mortality
Time Frame
2 years
Title
Post-treatment Pulmonary Function
Description
Post-treatment Pulmonary Function measured by pulmonary function testing (spirometry)
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patient must be > 18 years of age
Two or more GGO's or solid lesions suspicious for multifocal disease.
Clinical diagnosis of N0
No evidence of distant metastases
No prior intra-thoracic radiation therapy (NOTE: Previous radiotherapy as part of treatment for head and neck, breast, or other non-thoracic cancer is permitted.), previous chemotherapy, or surgical resection for non-small cell lung cancer (NSCLC).
No other cancer in the past 5 years except early stage prostate cancer, or basal cell of skin.
PFT's that show patient is capable of tolerating a lung resection.
Non-pregnant and non-lactating. Women of child-bearing potential must have a negative urine or serum pregnancy test to participate in the study.
Patient must be able to understand and willing to sign an IRB-approved informed consent document.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Wigle, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Treatment of Multifocal Lung Adenocarcinoma
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