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Treatment of Multifocal Lung Adenocarcinoma

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01946100
Enrollment
100
Registered
2013-09-19
Start date
2013-11-06
Completion date
2025-05-29
Last updated
2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

multifocal, genetic, bronchoalveolar carcinoma, adenocarcinoma in situ, ground glass opacity, next generation sequencing

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.

Interventions

GENETICMultifocal Lung Adenocarcinoma

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

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Overall Survival2 yearsOverall survival compared to survival for Stage IV NSCLC on NCCTG trials

Secondary

MeasureTime frameDescription
Treatment Morbidity and Mortality2 yearsTreatment Morbidity and Mortality
Post-treatment Pulmonary Function2 yearsPost-treatment Pulmonary Function measured by pulmonary function testing (spirometry)
Progressive free survivalEvery 3 months for 2 yearsProgressive free survival

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026