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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
Sponsor:
Collaborators:
Samsung Medical Center
Chungnam National University Hospital
Information provided by (Responsible Party):
Byung-Kiu Park, National Cancer Center, Korea

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 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

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

  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
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




Primary Outcome Measures :
  1. 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.)


Secondary Outcome Measures :
  1. tumor necrosis rate [ Time Frame: Until study completion, an average of 3years ]
    necrosis rate of the excised tumor after neoadjuvant chemotherapy

  2. 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



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Ages Eligible for Study:   up to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed osteosarcoma patients under age 40 years.

Exclusion Criteria:

  • Patients who don't meet the organ function criteria as follows;

    1. renal function : CCr or GFR or eGFR ≥ 70 mL/min/1.73 m2
    2. liver function : AST/ALT ≤ 5 x upper limit, total bilirubin ≤ 1.5 x upper limit of normal for age
    3. cardiac function : shortening fraction ≥ 24% or ejection fraction ≥ 50% (Echo)
    4. lung function : No dyspnea on rest, If dyspnea exists, SpO2 95% or more in room air by pulse oximetry,
    5. hematologic : ANC ≥ 750/uL and platelet ≥ 75,000/uL

Information from the National Library of Medicine

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


Contacts
Contact: Byung-Kiu Park, M.D., Ph.D. 82-31-920-1240 bkpark@ncc.re.kr

Locations
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    bkpark@ncc.re.kr   
Contact: Mi Mi Kwon, RN    82-31-920-1240    rnjsalal@ncc.re.kr   
Sponsors and Collaborators
Byung-Kiu Park
Samsung Medical Center
Chungnam National University Hospital
Investigators
Principal Investigator: Byung-Kiu Park, M.D., Ph.D. National Cancer Center

Publications:
Responsible Party: Byung-Kiu Park, Prof., National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT03390946     History of Changes
Other Study ID Numbers: NCC-OSA-1601
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Clinical data of individual participants can be shared without personal information. Each participating center will submit the clinical data to the principal investigation center, after eliminating personal data.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Byung-Kiu Park, National Cancer Center, Korea:
four-drugs, interval-compression

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Cisplatin
Doxorubicin
Methotrexate
Ifosfamide
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Dermatologic Agents
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antineoplastic Agents, Alkylating