JPRN-jRCTs031180425进行中(未招募)2 期
Phase II study of radiation with concomitant intra-arterial cisplatin infusion chemotherapy for maxillary sinus cancer - Phase II study of RADPLAT for maxillary sinus cancer
Tanaka Norimitsu0 个研究点目标入组 44 人开始时间: 2019年3月25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
- 44
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.Maxillary sinus cancer pathologically proved as squamous cell carcinoma
- •2.Maxillary sinus cancer staged as T3 and T4 on UICC, 2009.
- •3.No metastatic lymph node
- •4.Primary treatment case
- •5.Measurable disease
- •6.Cather accessible case into the feeding arteries, including internal maxillary artery, facial artery and transverse facial artery.
- •7.Pursuing of non-surgical and organ-preserving treatment, but salvage surgery for residual cancer can be done.
- •8.Age of the patient: >=20 y.o. and <=75 y.o.
- •9.Prognosis better than 8 months
- •10. ECOG Performance status (PS) 0 or 1
排除标准
- •1)Bone suppression state
- •2)Severe infection in the head and neck region
- •3)Severe systemic complication, such as intestinal paralysis, ileus, interstitial pneumonitis, pulmonary fibrosis, uncontrolled DM, heart failure, renal failure, and liver failure.
- •4)Synchronized active cancer
- •5)History of irradiation for head and neck region
- •6)History of allergy for cisplatin or contrast medium
- •7)Severe mental disorder
- •8)Pregnant, unwell to practice contraception during the study or lactating female
- •9)Preoperative therapy for planed surgery
- •10)Inaccessible catheterization due to arteriosclerosis
- •11)Other causes judged unpreferable by attending physician for this protocol treatment
研究者
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