Phase 2 Study of Anti-angiogenetic Therapy With Radiotherapy for Pediatric Neuroblastoma
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Radiotherapy plus Endostar(Recombinant Human Endostatin) in patients with Pediatric Neuroblastoma.
详细描述
Clinical data proved that Endostar was a wild spectrum and safe antiangiogenesis factor which could suppress almost 65 kinds of tumor mass in animal models and affect about 12 percent human genome. So investigators design Radiotherapy plus Endostar to treat Pediatric Neuroblastoma to research the RR and safety. Investigators believe this treatment regimen may be a new approach to the pediatric neuroblastoma patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have histologically confirmed neuroblastoma or ganglioneuroblastoma or elevated urinary catecholamine metabolites.
- •Life expectancy of greater than 12 months.
- •ECOG performance status ≤2
- •Diagnostic Imaging MRI and/or CT of the area to be treated within 8 weeks of any treatment. Baseline bone marrow biopsy and bone scan (with 99mTc-diphosphonate or MIBG scan (131I-MIBG or 123I-MIBG) from time of original diagnosis is required.
- •Because radiation is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •Ability of the patient or the patient's legal guardian to understand and the willingness to sign a written informed consent document.
- •Participants or their legal guardian must sign consent prior to the initiation of radiation therapy.
排除标准
- •Patients will be ineligible if any prior therapeutic radiation therapy > 500 cGy has been delivered.
- •Patients will be ineligible if chemotherapy was completed ≥ 1 year from the planned start date of radiation therapy or if the patient is referred for radiation therapy after a relapse following a regimen with chemotherapy alone.
- •Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
- •Pregnant females are excluded. Women of childbearing age/menstruating must have a negative pregnancy test prior to initiation of radiation therapy.
研究组 & 干预措施
Endostar Combined With Radiotherapy
Drug: Endostar Endostar 7.5 mg/m2/day, day 1-14 Radiation: 21.6Gy/12Fx to the tumor bed and 36Gy/20Fx to the tumor
干预措施: Endostar (Drug)
Endostar Combined With Radiotherapy
Drug: Endostar Endostar 7.5 mg/m2/day, day 1-14 Radiation: 21.6Gy/12Fx to the tumor bed and 36Gy/20Fx to the tumor
干预措施: 21.6Gy/12Fx to the tumor bed and 36Gy/20Fx to the tumor (Radiation)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: first analysis will occur 1 month after accrual of all patients
次要结局
- Overall survival (OS)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months)
- Objective response rate (ORR)(first analysis will occur 1 month after accrual of all patients)
- Progression free survival(PFS)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months)
研究者
Chuanying Zhu
doctor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine