NCT02566421

Genomic Sequencing in Determining Treatment in Patients With Metastatic Cancer or Cancer That Cannot Be Removed by Surgery

Precision Medicine for Patients With Malignancy at the Comprehensive Cancer Center of Wake Forest University

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies patients' genomic sequencing in determining specific treatments, also called Precision Medicine, in patients with cancer that has spread to other parts of the body (metastatic) and/or cannot be removed by surgery. Examining the genetic code of a patient's tumor, a mutation (a change in the deoxyribonucleic acid \[DNA\] sequence of a cell or gene) may be identified and matched with available treatment that targets the mutated gene or an alternative treatment that may provide benefit for the patient with the mutation identified. Precision medicine may impacts patient's response to treatment by targeting specific mutations and may increase survival and improve quality of life.

Detailed description

PRIMARY OBJECTIVES: I. To assess the feasibility of implementing a Precision Oncology protocol in the treatment of patients who undergo genomic sequencing. SECONDARY OBJECTIVES: I. To determine treatment response rates in patients who receive targeted treatment versus those who do not receive targeted treatment. II. To assess survival in patients who receive targeted treatment versus those who do not receive targeted treatment. III. To assess changes in patient-reported outcomes in patients who receive targeted treatment versus those who do not receive targeted treatment. IV. To perform exploratory statistical genetic and bioinformatics analyses using the data derived from the genomic sequencing to catalogue additional important variants and determine whether there are any patterns or associations among patient level risk factors, their outcomes and genomic information that was not identified by the original genomic sequencing analyses. OUTLINE: Patients receive treatment based on the results of their genomic sequencing analyses. After completion of study treatment, patients are followed up every 2 months.

Conditions

• Metastatic Neoplasm
• Recurrent Neoplasm
• Recurrent Non-Small Cell Lung Carcinoma
• Stage IIIA Non-Small Cell Lung Cancer
• Stage IIIB Non-Small Cell Lung Cancer
• Stage IV Non-Small Cell Lung Cancer
• Unresectable Malignant Neoplasm

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Targeted Therapy	Receive treatment based on genomic sequencing

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2015-10-02
• Last updated: 2018-07-02

Locations

1 site across 1 country: United States