Treatment of Multifocal Lung Adenocarcinoma

Mayo Clinic

Status

Active, not recruiting

Conditions

Lung Neoplasms

Carcinoma Non-small-cell Lung

Adenocarcinoma

Treatments

Genetic: Multifocal Lung Adenocarcinoma

Study type

Interventional

Funder types

Other

Identifiers

NCT01946100

12-007569

Details and patient eligibility

About

To gather preliminary safety and outcome data for the multimodality treatment of lung adenocarcinoma in the setting of multifocal BAC.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.