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Brief Title: Next Generation Sequence Target-Directed Therapy in Treating Patients With Cancer
Official Title: A Prospective Randomized Trial Comparing the Effectiveness of Physician Discretion Guided Therapy Versus Physician Discretion Guided Plus Next-Generation Sequence Directed Therapy
Study ID: NCT02132845
Brief Summary: This randomized clinical trial studies how well next generation sequence target-directed therapy works in treating patients with cancer. Next generation sequencing is a test that screens for mutations to cancer related genes. Target-directed therapy is a type of treatment that uses drugs or other substances to identify and attack specific types of cancer cells that may have less harm to normal cells. Next generation sequencing may help identify these specific types of cancer cells.
Detailed Description: PRIMARY OBJECTIVES: I. Overall (composite) response rate (ORR). SECONDARY OBJECTIVES: I. 4-month progression free survival (PFS). II. Mutation rate. III. Adverse event rate/severity. IV. Overall survival. TERTIARY OBJECTIVES: I. Targeted agent rate. II. Available protocol rate. III. Protocol enrollment rate. IV. Disease site influence. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients undergo collection of tissue and blood samples for analysis via next generation sequencing. Patients receive standard of care therapy based on the discretion of the treating physician. ARM B: Patients undergo collection of tissue and blood samples for analysis via next generation sequencing. Based on the results of the next generation sequencing, patients receive target-directed therapy. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Name: Anthony Olszanski
Affiliation: Fox Chase Cancer Center
Role: PRINCIPAL_INVESTIGATOR