Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03390946
Study type Interventional
Source National Cancer Center, Korea
Contact Byung-Kiu Park, M.D., Ph.D.
Phone 82-31-920-1240
Email bkpark@ncc.re.kr
Status Not yet recruiting
Phase Phase 2
Start date February 1, 2018
Completion date December 31, 2020

See also
  Status Clinical Trial Phase
Completed NCT00026780 - Eligibility Screening for a NCI Pediatric Oncology Branch Research Study
Not yet recruiting NCT05515068 - Registry For Children, Adolescents And Adults With Osteosarcoma And Biologically Related Bone Sarcomas
Completed NCT02383901 - A Retrospective Non-intervention Study to Characterize FOlate Rescue Treatment in Osteosarcoma Patients Treated With HDMTX N/A
Active, not recruiting NCT01758666 - A Clinical Research on the Relation of Blood Drug Concentration and Calcium Folinate Rescued in High-dose MTX Therapy N/A
Completed NCT01674101 - Effects of Preoperative Physical Therapy in Patients With Lower Extremity Malignancy N/A
Completed NCT01615640 - Diffusion Study on Patients With Osteosarcoma
Completed NCT00523419 - Chemotherapy for Patients With Osteosarcoma Phase 2
Completed NCT00520936 - A Study of Pemetrexed in Children With Recurrent Cancer Phase 2
Completed NCT00132158 - ZD1839 and Oral Irinotecan in Treating Young Patients With Refractory Solid Tumors Phase 1
Not yet recruiting NCT04319874 - Phase II Clinical Trial Scheme of Ganoderma Lucidum Spore Powder for Postoperative Chemotherapy of Osteosarcoma Phase 2
Recruiting NCT06029218 - Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy N/A
Recruiting NCT05642455 - SPEARHEAD-3 Pediatric Study Phase 1/Phase 2
Recruiting NCT06117878 - Safety and Efficacy of NK510 to Treat Osteosarcoma and Soft Tissue Sarcoma Early Phase 1
Not yet recruiting NCT04316091 - A Phase I Clinical Trial of Neoadjuvant Chemotherapy With/Without SPIONs/SMF for Patients With Osteosarcoma Phase 1
Recruiting NCT03932058 - Proteomics Research of Osteosarcoma
Withdrawn NCT01236586 - RO4929097 in Children With Relapsed/Refractory Solid or CNS Tumors, Lymphoma, or T-Cell Leukemia Phase 1
Completed NCT00743496 - A Phase I Trial Of The Humanized Anti-GD2 Antibody In Children And Adolescents With Neuroblastoma, Osteosarcoma, Ewing Sarcoma and Melanoma Phase 1
Recruiting NCT04040205 - Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration Phase 2
Recruiting NCT05970497 - A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors Phase 1
Active, not recruiting NCT03628209 - Nivolumab or Nivolumab and Azacitidine in Patients With Recurrent, Resectable Osteosarcoma Phase 1/Phase 2