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Spots Global Cancer Trial Database for Next Generation Sequence Target-Directed Therapy in Treating Patients With Cancer

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 19 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

Contact Details

Name: Anthony Olszanski

Affiliation: Fox Chase Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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