jRCT2080224571已完成2 期
Phase II trial of the combination of SPM-011 and BNCT System (BNCT30) for unresectable locally recurrent HNSCC or unresectable HNNSCC
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Tumor resuponse (response rate)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Multi-center, open label, single armed study
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •(1) Document consent by his/her own free will
- •(2) 20 years old or older
- •(3) 60% of Karnofsky Performance Status (KPS) or higher
- •(4) The primary lesion is histologically head and neck cancer
- •(5) At least one measureable lesion in the target lesion site based on RECIST (version 1.1)
- •(6) Prior radiation therapy satisfying one of the following conditions:
- •(6) Prior radiation therapy satisfying one of the following conditions:
- •For locally recurrent squamous cell carcinoma:
- •Radiation therapy, fractionation around 2Gy/day, total dose within the range of 40 - 75 Gy
- •For non-squamous cell carcinoma:
- •No prior radiation therapy
- •Radiation therapy, not more than 75 Gy of total biologically effective dose
- •(7) 90 days or more have passed since the last irradiation date of prior radiation therapy for the evaluation target lesion site to the scheduled date of BNCT, except for non-squamous cell carcinoma with no history of prior radiation therapy
- •(8) Over 90 days of survival is expected after BNCT.
- •(9) Non problematic disorder (Screening test)
排除标准
- •(1) Active multiple primary cancers
- •(2) Distant metastasis
- •(3) Active infections requiring systemic treatment
- •(4) Serious Complications
结局指标
主要结局
Tumor resuponse (response rate)
时间窗: within 90 days after BNCT
Tumor response was evaluated within 90 days after BNCT using RECIST (version 1.1). Response rate is defined as the ratio of the number of cases with CR or PR of the evaluated lesions to the number of all eligible cases.
次要结局
未报告次要终点
研究者
研究点 (1)
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