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Next Generation Sequence Target-Directed Therapy in Treating Patients With Cancer

Malignant Neoplasm Clinical Trial

Official title:
A Prospective Randomized Trial Comparing the Effectiveness of Physician Discretion Guided Therapy Versus Physician Discretion Guided Plus Next-Generation Sequence Directed Therapy

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02132845
Study type Interventional
Source Fox Chase Cancer Center
Contact
Status Completed
Phase N/A
Start date March 17, 2016
Completion date May 10, 2018
View Details
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