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Treatment of Multifocal Lung Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01946100
Recruitment Status : Active, not recruiting
First Posted : September 19, 2013
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Dennis Wigle, Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Lung Neoplasms Carcinoma Non-small-cell Lung Adenocarcinoma Genetic: Multifocal Lung Adenocarcinoma Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Pathway for the Treatment of Multifocal Lung Adenocarcinoma Using Genome Sequencing
Study Start Date : October 2013
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 2 years ]
    Overall survival compared to survival for Stage IV NSCLC on NCCTG trials


Secondary Outcome Measures :
  1. Progressive free survival [ Time Frame: Every 3 months for 2 years ]
    Progressive free survival

  2. Treatment Morbidity and Mortality [ Time Frame: 2 years ]
    Treatment Morbidity and Mortality

  3. Post-treatment Pulmonary Function [ Time Frame: 2 years ]
    Post-treatment Pulmonary Function measured by pulmonary function testing (spirometry)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01946100


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Dennis Wigle, MD, PhD Mayo Clinic

Additional Information:
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Responsible Party: Dennis Wigle, MD, PhD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01946100     History of Changes
Other Study ID Numbers: 12-007569
First Posted: September 19, 2013    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Keywords provided by Dennis Wigle, Mayo Clinic:
multifocal
genetic
bronchoalveolar carcinoma
adenocarcinoma in situ
ground glass opacity
next generation sequencing
Additional relevant MeSH terms:
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Adenocarcinoma
Lung Neoplasms
Adenocarcinoma of Lung
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases