Single Arm Phase 2 Study to Verify the Efficacy and safety of THP-based therapy for High-grade osteosarcoma of Extremity, rib, and sternum in pediatric and AYA patients to Reduce Toxicity (SAVE HEART)

未提供0 个研究点目标入组 55 人开始时间: 待定最近更新: 2025年3月19日

试验速览

阶段: 不适用
状态: 招募中
入组人数: 55
主要终点: -

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Single Arm Study
干预模型: Single Assignment
主要目的: Treatment Purpose
盲法: Open(masking Not Used)

入排标准

年龄范围: No limit 至 40age old under（—）
性别: All

入选标准

•Patients diagnosed with high-grade osteosarcoma based on the images of the primary tumor and the histopathological diagnosis of the tumor material obtained via biopsy. The histological classification should be according to the 4th edition of the Japanese Code of Medical Practice for Malignant Bone Tumors. Regardless of when, biopsy should be performed prior to registration. However, if biopsy was performed in another hospital, the pathological diagnosis must be made by a pathologist at the medical institution where the clinical trial is conducted by ordering a pathological specimen.
•Patients with a primary lesion located in the upper limb including the upper limb girdle, the lower limb including the lower limb girdle, the sternum, and the ribs. However, patients with primary lesions in the lower limb girdle extending beyond the sacroiliac joint to the sacrum are not eligible.
•Patients with resectable primary lesion
•Patients with lesions classified as clinical stage IIA, IIB, or III according to the 8th edition of the Union for International Cancer Control TNM classification. For patients with a primary lesion located in the pelvic region, clinical staging should be conducted in accordance with the 7th edition.
•Patients aged <=40 years upon enrollment
•Patients with an Eastern Cooperative Oncology Group-performance status score of 0 or 1 and those without local symptoms such as bone fractures
•Patients without a history of osteosarcoma and those with low- or high-grade lesions regardless of the site of origin
•Patients without a history of chemotherapy or radiation therapy including treatment for other types of cancer.
•Patients without any of the following:
•(1) Signs fulfilling the definition of Li-Fraumeni syndrome
•(2) History of retinoblastoma
•Patients who underwent laboratory tests performed within 14 days prior to the date of enrollment (the same day of the week 2 weeks prior to the date of enrollment is acceptable) and who meet the following criteria:
•(1) White blood cell count >= 3,000/mm3
•(2) Neutrophil count >= 1,500/mm3
•(3) Platelet count >= 100,000/mm3
•(4) Hemoglobin level >= 8.0 g/dL
•(5) AST level <= 100 U/L
•(6) ALT level <= 100 U/L
•(7) Total bilirubin level <= 1.5 mg/dL
•(8) Creatinine level <= 1.2 mg/dL (serum creatinine level <= 0.8 mg/dL for patients aged <= 10 years)
•(9) Creatinine clearance >= 70 mL/min
•Patients with normal results on the most recent 12-lead resting ECG performed within 28 days of enrollment (the same day of the week 4 weeks prior to enrollment is acceptable) or those without grade 2 or higher abnormality based on the Common Terminology Criteria for Adverse Events version 5.
•Patients with a left ventricular ejection fraction (LVEF) of >= 60% on the last transthoracic echocardiogram conducted within 28 days prior to enrollment (same day of the week 4 weeks prior to enrollment is acceptable).
•Written informed consent to participate in the study is obtained from patients aged >=16 years. If the patient is a minor aged >=16 years, written informed consent is obtained from the patients and their surrogates.

排除标准

•Patients with complex diabetes mellitus that is being treated with continuous insulin use or those with poorly controlled glucose levels (HbA1c level >= 6.5%)
•Patients with uncontrolled hypertension
•Patients with a history of myocardial infarction or unstable angina pectoris
•Patients with a cardiac pacemaker
•Patients with an infectious disease requiring systemic treatment
•Patients with fever (> 38 degrees Celsius, not including tumor fever that can be ruled out as infection)
•Patients with multiple active cancers (synchronous multiple cancers and iatrogenic multiple cancers with a disease-free interval of <= 5 years). However, carcinoma in situ (intraepithelial carcinoma) and intramucosal carcinoma equivalent lesions that can be cured with local treatment are not classified as active multiple cancers.
•Pregnant, potentially pregnant, or lactating women
•Patients with psychiatric disorders or psychiatric symptoms that could interfere with participation in this study
•Patients receiving continuous systemic administration of steroids (oral or intravenous)
•Patients who tested positive for HBs antigen, HBc antibody, or HBs antibody. However, they may be enrolled if only HBs antibody is present and there is a documented history of hepatitis B vaccination or the HBV-DNA quantification is less than the detection sensitivity)
•Patients who tested positive for HIV antibody, HTLV-1 antibody, or HCV antibody. Patients with positive HCV antibodies but without detectable HCV-RNA should be excluded. All of these must be confirmed via blood test.

结局指标

主要结局

3-Year disease-free survival

次要结局

未报告次要终点

研究者

发起方

未提供

相似试验

已完成

3 期

Please refer to ClinicalTrials.gov : NCT04241068.Alzheimer's disease

JPRN-jRCT2080225185Biogen Japan Ltd.2,400

进行中（未招募）

1 期

Phase I trial; HMR code: 24-003Healthy volunteers

ISRCTN16055614Sling Therapeutics, Inc.20

进行中（未招募）

1 期

Phase I trial, Quotient Code: QSC300414The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.

ISRCTN85847953D. E. Shaw Research104

终止

2 期

Please refer to ClinicalTrials.gov : NCT03954041Brain Contusion

JPRN-jRCT2080224849Biogen Japan Ltd.160

进行中（未招募）

1 期

Phase 1 trial, HMR code: 21-004The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record when the results are published, which will be within 30 months after the trial has ended.Not Specified

ISRCTN12926361Gedeon Richter Plc104