Feasibility Study of Interval Compressed Regimen Using Four-drugs for Osteosarcoma
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|ClinicalTrials.gov Identifier: NCT03390946|
Recruitment Status : Not yet recruiting
First Posted : January 5, 2018
Last Update Posted : January 9, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteosarcoma Feasibility Treatment Response Biomarker||Drug: Poor responder group adjuvant chemotherapy Drug: Good responder group adjuvant chemotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Study of Interval Compressed Regimen Using Four-drugs for Osteosarcoma|
|Estimated Study Start Date :||February 1, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: four-drug interval-compressed regimen
Interventions for 'four-drug interval-compressed regimen': Drug: methotrexate, cisplatin, doxorubicin, ifosfamide.
Newly diagnosed oseteosarcoma patients under 40 years are eligible. Neoadjuvant chemotherapy with four drugs in an interval-compressed schedule will be done as a single arm.
Duration of neoadjuvant chemotherapy will be 10 weeks like that of conventional three-drug regimen, although four-drugs are employed in the current protocol.
After tumor resection operation, participants will be divided to poor responder group and good responder group based on 90% necrosis rate of a tumor specimen.
Poor responder group and will be assigned to 'Poor responder group adjuvant chemotherapy' and good responder will be assigned to 'Good responder group adjuvant chemotherapy'.
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
Other Name: PR adjuvant four-drug interval-compressed regimen
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
Other Name: GR adjuvant four-drug interval-compressed regimen
- Toxicity determined according to CTCAE [ Time Frame: Until study completion, an average of 3 years ]treatment-related toxicity (organ dysfunction, neutropenic fever, infection, mortality, et al.)
- tumor necrosis rate [ Time Frame: Until study completion, an average of 3years ]necrosis rate of the excised tumor after neoadjuvant chemotherapy
- Predictive or prognostic biomarker [ Time Frame: Until study completion, an average of 3 years ]Usefulness of circulating cell-free DNA, survivin, transforming growth factor-beta1 levels and programmed cell death 1 expression in tumor specimen as a biomarker
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03390946
|Contact: Byung-Kiu Park, M.D., Ph.D.||firstname.lastname@example.org|
|Korea, Republic of|
|National Cancer Center||Not yet recruiting|
|Goyang-si, Gyeonggi, Korea, Republic of, 10408|
|Contact: Byung-Kiu Park, M.D., Ph.D. 82-31-920-1240 email@example.com|
|Contact: Mi Mi Kwon, RN 82-31-920-1240 firstname.lastname@example.org|
|Principal Investigator:||Byung-Kiu Park, M.D., Ph.D.||National Cancer Center|