Treatment of Multifocal Lung Adenocarcinoma

Not Applicable

Active, not recruiting

• Conditions: Lung Neoplasms; Carcinoma Non-small-cell Lung; Adenocarcinoma
• Interventions: Genetic: Multifocal Lung Adenocarcinoma

• Registration Number: NCT01946100
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2013-09-16
• Study First Submitted QC: 2013-09-18
• Study First Posted: 2013-09-19
• Study Start: 2013-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Multifocal Lung Adenocarcinoma	Multifocal Lung Adenocarcinoma	-

Primary Outcome Measures

Name	Time	Method
Overall Survival	2 years	Overall survival compared to survival for Stage IV NSCLC on NCCTG trials

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States