JPRN-jRCTs051220137招募中1 期
Phase I/II trial of induction chemotherapy with bi-weely Docetaxel, Carboplatin, Cetuximab for locally advanced unresectable head and neck cancer.
Kiyota Naomi0 个研究点目标入组 43 人开始时间: 2022年12月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 43
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 ot applicable（—）
- 性别
- All
入选标准
- •Histologically proven squamous cell carcinoma of head and neck
- •- Primay site of Oral, Oropharynx, Hypopharynx, Larynx.
- •Locally advanced head and neck cancer patient.
- •Age 20 years or older, signed informed consent obtained before any study specific procedures.
- •No previous chemotherapy, No previous radiation therapy for brain, head and neck region.
- •No previous surgery for head and neck cancer
- •ECOG-PS of 0 to 1.
- •Adequate bone marrow, liver function assessed within 14 days before starting study treatment.
- •- Neutrophils counts >= 1500/mm3
- •- Hb >= 9.0 g/dl
- •- Platelet counts>= 100,000/mm3
- •- Total bilirubin: =< 1.5 mg/dl (In case of patient with constitutional jaundice, total bilirubin is allowed =< 3.0 mg/dl)
- •- AST/ALT =< 100/100 IU/l
- •- Cr<1.5mg/dl
排除标准
- •Active concomitant malignancy except carcinoma in situ or intramucosal tumor within 5 years before study entry.
- •Active uncontrolled infection disease needed treatment.
- •HIV infected patient.
- •Lung fibrosis, acute lung damage or intestinal lung disease.
- •Peripheral neuropathy CTCAE Grade 2.
- •Hemodialysis patients.
- •Severe allergy/infusion reaction (Grade 3/4) or side effect for docetaxel, carboplatin or cetuximab.
- •Allergy for beef or Ticks
研究者
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