NCT05883007进行中（未招募）1 期
Safety Cohort Study for Dose Optimization of Accelerator-based BPA-BNCT in Patients With Unresectable Locally Recurrent Squamous Cell Carcinoma of the Head and Neck (ST-BNCT2001)
Southern Tohoku BNCT Research Center2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Adverse events (Absence and presence of serious adverse events)
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety of applying BNCT with the dose optimization in patients with recurrent head and neck cancer. The main questions it aims to answer are:
- Dose optimized BNCT are conducted safety in these patients. Participants will receive dose optimized BNCT regulated as 12, 15, 18 Gy-Eq of the mucosal dose.
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
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent to participate in the clinical trial on their own free will.
- •Aged over 20 years at the time of consent obtaining.
- •ECOG performance status (PS) of 0-
- •Histologically confirmed a primary lesion of Head and Neck cancer.
- •Following condition:
- •Locally Recurrent Head and Neck Squamous Cell Carcinoma after chemo radiotherapy or radiation therapy.
- •Primary Head or Neck Squamous Cell Carcinoma with no indicated of radical radiation therapy for the target lesions.
- •More than one the target lesions based on RECIST (version 1.1)
- •Local recurrent lesion localized to unilateral.
- •Received a fractionated radiation therapy with total doses of ≥40 and ≤80 Gy at around 2 Gy per daily fraction at target lesion sites or an equivalent biologically effective dose.
- •≥50 days have passed since the last irradiation date of the prior radiation therapy at target lesion sites to the day of scheduled BNCT
- •Have an estimated survival of ≥90 days after BNCT.
- •Estimated able to receive the minimum tumor dose at least 20Gy-Eq.
- •Screening test values that meet the following criteria.
- •No abnormal findings of clinical concern in chest X-ray exam.
排除标准
- •Active multiple primary cancers.
- •Distant metastatic lesions.
- •Active infections requiring systemic treatment.
- •Serious complications.
- •Poorly controlled diabetes mellitus.
- •Poorly controlled hypertension.
- •Chronic lung diseases.
- •Kidney diseases.
- •Cardiac diseases.
- •Other serious complications.
- •Phenylketonuria.
- •Hereditary fructose intolerance.
- •Current or past medical history of serious hypersensitivity to drugs or contrast media.
- •Myocardial infarction, unstable angina, or poorly controlled arrhythmia within 6 months prior to the scheduled BNCT.
- •Grade ≥3 (CTCAE v4.0) symptom at the target site.
- •Tumor invasion of the carotid artery or adjacent to over half of the carotid artery.
- •Dental caries whose treatment has not been completed.
- •Received antitumor drugs within 4 weeks prior to the scheduled BNCT.
- •Participating in a clinical study of an unapproved drug except 18F-F BPA-PET/CT examinations within 4 weeks prior to the scheduled BNCT.
- •Implanted with a cardiac pacemaker, ventricular assist device, or the like.
- •Inability to immobilize at a right position during irradiation by the investigator (subinvestigator)
- •Pregnant or who are breastfeeding during the period of the clinical trial.
- •Mental illness or mental conditions.
- •Poorly controlled epilepsy.
- •Unable to comply with the protocol and to attend follow-up visits.
- •With a history of BNCT.
- •Considered unfit to participate in this clinical trial as assessed by the investigator.
结局指标
主要结局
Adverse events (Absence and presence of serious adverse events)
时间窗: Within 90days after the completion of BNCT
Grade 3 or higher adverse events as evaluated in CTCAEv5.1 Number of participants with severe adverse events due to an excess of tissue tolerance dose
次要结局
- Disease control rate (DCR)(Within 90 days after the completion of BNCT)
- Late Adverse Events(From 90 days to 2 years after the completion of BNCT)
- Quality of life (QOL) Score Based on EORTC QLQ C30 and H&N35.(Within 2 years after the completion of BNCT or up to the end of this study)
- Objective response rate: ORR(Within 90 days after the completion of BNCT)
- Duration of Response(Within 2 years after the completion of BNCT)
- Progression-Free Survival (PFS)(Within 2 years after the completion of BNCT or up to the end of this study)
- Overall survival (OS)(Within 2 years after the completion of BNCT or up to the end of this study)
- Quality-Adjusted Life Year (QALY)(Within 2 years after the completion of BNCT or up to the end of this study)
研究者
研究点 (2)
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