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

NCT03390946 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2018-01-09

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Samsung Medical Center

    collaborator OTHER

  • Chungnam National University Hospital

    collaborator OTHER

  • Byung-Kiu Park

    lead OTHER_GOV

Principal Investigators

  • Byung-Kiu Park, M.D., Ph.D. · National Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03390946 on ClinicalTrials.gov