Spots Global Cancer Trial Database for Feasibility Study of Interval Compressed Regimen Using Four-drugs for Osteosarcoma

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Trial Identification

Brief Title: Feasibility Study of Interval Compressed Regimen Using Four-drugs for Osteosarcoma

Official Title: Feasibility Study of Interval Compressed Regimen Using Four-drugs for Osteosarcoma

Study ID: NCT03390946

Conditions

Interventions

Poor responder group adjuvant chemotherapy

Good responder group adjuvant chemotherapy

Study Description

Brief Summary: The aim of the study is to test the feasibility of four-drug, interval-compressed regimen in osteosarcoma. Primary objective is to explore the toxicity and mortality related to treatment. Secondary objectives are to examine tumor necrosis rates after neoadjuvant chemotherapy, and to evaluate the usefulness of circulating cell-free DNA, survivin, or transforming growth factor-beta1 levels as well as programmed cell death ligand 1 expression in tumor specimen as a predictive or prognostic biomarker in osteosarcoma patients.

Detailed Description: In this study, the investigators will investigate the feasibility of interval compressed regimen using four-drugs in newly-diagnosed osteosarcoma patients. Four drugs will be adriamycin, high-dose methotrexate, cisplatin, ifosfamide. All these drugs will be given preoperatively in an interval-compressed schedule, but postoperatively at a regular interval. Neoadjuvant therapy will be composed of two courses, and adjuvant therapy of two or three courses depending on necrosis rates following neoadjuvant therapy.