Treatment of Multifocal Lung Adenocarcinoma

Lung Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01946100
• Other study ID #: 12-007569
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2013
• Est. completion date: October 2025

Study information

• Verified date: November 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• Carcinoma Non-small-cell Lung
• Lung Neoplasms

Intervention

Genetic:
• Multifocal Lung Adenocarcinoma
Tissue collection at the time of surgery for genetic testing and blood sample for germ line DNA.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Overall survival compared to survival for Stage IV NSCLC on NCCTG trials	2 years
Secondary	Progressive free survival	Progressive free survival	Every 3 months for 2 years
Secondary	Treatment Morbidity and Mortality	Treatment Morbidity and Mortality	2 years
Secondary	Post-treatment Pulmonary Function	Post-treatment Pulmonary Function measured by pulmonary function testing (spirometry)	2 years

External Links

•   Mayo Clinic Clinical Trials