Treatment of Multifocal Lung Adenocarcinoma

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

Detailed Description
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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.

Official Title
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A Clinical Pathway for the Treatment of Multifocal Lung Adenocarcinoma Using Genome Sequencing

Conditions
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Lung Neoplasms, Carcinoma Non-small-cell Lung, Adenocarcinoma

Intervention / Treatment
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* Genetic: Multifocal Lung Adenocarcinoma


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Multifocal Lung Adenocarcinoma<br> | Genetic: Multifocal Lung Adenocarcinoma<br>* Tissue collection at the time of surgery for genetic testing and blood sample for germ line DNA.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Overall survival compared to survival for Stage IV NSCLC on NCCTG trials | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progressive free survival | Progressive free survival | Every 3 months for 2 years | 
| Treatment Morbidity and Mortality | Treatment Morbidity and Mortality | 2 years | 
| Post-treatment Pulmonary Function | Post-treatment Pulmonary Function measured by pulmonary function testing (spirometry) | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multifocal, genetic, bronchoalveolar carcinoma, adenocarcinoma in situ, ground glass opacity, next generation sequencing