Clinical trial NCT01946100: Treatment of Multifocal Lung Adenocarcinoma
Official title: A Clinical Pathway for the Treatment of Multifocal Lung Adenocarcinoma Using Genome Sequencing
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Neoplasms
Carcinoma Non-small-cell Lung
Adenocarcinoma
Keywords: multifocal
genetic
bronchoalveolar carcinoma
adenocarcinoma in situ
ground glass opacity
next generation sequencing
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Overall Survival
timeFrame: 2 years
Secondary outcomes:
measure: Progressive free survival
timeFrame: Every 3 months for 2 years
measure: Treatment Morbidity and Mortality
timeFrame: 2 years
measure: Post-treatment Pulmonary Function
timeFrame: 2 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Dennis Wigle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: