Status:
UNKNOWN
Feasibility Study of Interval Compressed Regimen Using Four-drugs for Osteosarcoma
Lead Sponsor:
Byung-Kiu Park
Collaborating Sponsors:
Samsung Medical Center
Chungnam National University Hospital
Conditions:
Osteosarcoma
Feasibility
Eligibility:
All Genders
Up to 40 years
Phase:
PHASE2
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 o...
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 met...
Eligibility Criteria
Inclusion
- Newly diagnosed osteosarcoma patients under age 40 years.
Exclusion
- Patients who don't meet the organ function criteria as follows;
- renal function : CCr or GFR or eGFR ≥ 70 mL/min/1.73 m2
- liver function : AST/ALT ≤ 5 x upper limit, total bilirubin ≤ 1.5 x upper limit of normal for age
- cardiac function : shortening fraction ≥ 24% or ejection fraction ≥ 50% (Echo)
- lung function : No dyspnea on rest, If dyspnea exists, SpO2 95% or more in room air by pulse oximetry,
- hematologic : ANC ≥ 750/uL and platelet ≥ 75,000/uL
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT03390946
Start Date
February 1 2018
End Date
December 31 2020
Last Update
January 9 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea, 10408