NCT03390946

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (estimated)
• Sponsor: Byung-Kiu Park · Other Government
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteosarcoma
• Feasibility
• Treatment Response
• Biomarker

Interventions

Type	Name	Description
DRUG	Poor responder group adjuvant chemotherapy	Poor responder group (necrosis ≤ 90%) : week 0, 7 and 14, doxorubicin; week 2, 9 and 16, ifosfamde, week 4, 11, 18 and 19, methotrexate; wk 5, 12 and 20 B. Resection of tumor C. Adjuvant chemotherapy 1. Poor responder group (necrosis ≤ 90%) * week 0, 7 and 14, doxorubicin; week 2, 9 and 16, ifosfamde, week 4, 11, 18 and 19, methotrexate; wk 5, 12 and 20 2. Good responder group (necrosis \> 90%) * week 0 and 8, doxorubicin; week 2 and 10, ifosfamide; week 4, 5, 12 and 13, methotrexate; week 6 and 14, cisplatin
DRUG	Good responder group adjuvant chemotherapy	Good responder group (necrosis \> 90%) : week 0 and 8, doxorubicin; week 2 and 10, ifosfamide; week 4, 5, 12 and 13, methotrexate; week 6 and 14, cisplatin

Timeline

• Start date: 2018-02-01
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2018-01-05
• Last updated: 2018-01-09

Locations

1 site across 1 country: South Korea