JPRN-jRCTs031180135进行中（未招募）2 期
JCOG1008: Phase II/III Trial of Postoperative Chemoradiotherapy Comparing 3-Weekly Cisplatin with Weekly Cisplatin in High-risk Patients with Squamous Cell Carcinoma of Head and Neck - HNC-Adjuvant CDDP+RT-P3
TAHARA Makoto0 个研究点目标入组 260 人开始时间: 2019年2月19日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 260
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •1) Histologically proven squamous cell carcinoma in resected specimen
- •2) Primary lesion located at oral cavity, oropharynx, hypopharynx, or larynx. Primary site is diagnosed by surgical specimen.
- •3) Pathological stage III, IVA or IVB (UICC 7th edition)
- •4) high risk of locoregional recurrence defined as fulfilling i) and/or ii) by histological examination of surgical specimen
- •i) Microscopically positive resection margin
- •ii) Extracapsular nodal extension
- •5) Within 56 days from surgery
- •6) No distant metastasis in computed tomography within 28 days before registration
- •7) Aged 20 to 75 years old
- •8) ECOG performance status (PS) of 0 or 1
- •9) No prior radiation therapy, chemotherapy, nor hormonal therapy
- •10) Adequate organ functions
- •11) No clinically significant abnormal findings on electrocardiogram (ECG) within 28 days from the date of registration
- •12) Written informed consent
排除标准
- •1) Simultaneous or metachronous (within 5 years) double cancers except carcinoma in situ or intramucosal tumor with local therapy, and endoscopically confirmed carcinoma in situ or intramucosal tumor of esophagus, stomach and colorectum before registration.
- •2) Active systemic infections to be treated.
- •3) Body temperature of 38 or more degrees Celsius
- •4) Women during pregnancy, possible pregnancy, or breast-feeding
- •5) Patients who have psychosis or psychiatric symptoms are judged not to be able to participate in this clinical study
- •6) Continuous systemic steroid treatment (internal or intervenous use)
- •7) Uncontrolled diabetes mellitus
- •8) History of unstable angina pectoris (onset or worsening angina attack within 3 weeeks or a history of myocardial infarction within 6 months
- •9) Uncontrolled hypertension
- •10) Pleural effusion, pericardiac effusion, or ascites to be drained
- •11) Positive HBs antigen
- •12) Impossiblility to refrain from smoking or drinking during protocol treatment
研究者
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