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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
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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

First Posted
September 16, 2013
Last Updated
December 13, 2022
Sponsor
Mayo Clinic
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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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