Clinical Trial: Treatment of Multifocal Lung Adenocarcinoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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

Detailed Summary: 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.
Sponsor: Mayo Clinic

Current Primary Outcome: Overall Survival [ Time Frame: 2 years ]

Overall survival compared to survival for Stage IV NSCLC on NCCTG trials


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: September 16, 2013
Date Started: October 2013
Date Completion: October 2018
Last Updated: December 19, 2016
Last Verified: December 2016