Treatment of Multifocal Lung Adenocarcinoma

Sponsor

Mayo Clinic (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01946100

Collaborator

(none)

100

Enrollment

Location

Arm

120

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lung Neoplasms Carcinoma Non-small-cell Lung Adenocarcinoma	Genetic: Multifocal Lung Adenocarcinoma	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2013

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Multifocal Lung Adenocarcinoma	Genetic: Multifocal Lung Adenocarcinoma Tissue collection at the time of surgery for genetic testing and blood sample for germ line DNA.

Arm

Intervention/Treatment

Other: Multifocal Lung Adenocarcinoma

Genetic: Multifocal Lung Adenocarcinoma

Tissue collection at the time of surgery for genetic testing and blood sample for germ line DNA.

Outcome Measures

Primary Outcome Measures

Overall Survival [2 years]
Overall survival compared to survival for Stage IV NSCLC on NCCTG trials

Secondary Outcome Measures

Progressive free survival [Every 3 months for 2 years]
Progressive free survival
Treatment Morbidity and Mortality [2 years]
Treatment Morbidity and Mortality
Post-treatment Pulmonary Function [2 years]
Post-treatment Pulmonary Function measured by pulmonary function testing (spirometry)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.