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临床试验/JPRN-UMIN000003382
JPRN-UMIN000003382已完成未知

Phase 1 trial of neoadjuvant chemotherapy with S1 plus radiation in patients with locally advanced rectal cancer - Phase 1 trial of neoadjuvant chemotherapy with S1 plus radiation in patients with locally advanced rectal cancer

Toho University School of Medicine0 个研究点目标入组 12 人开始时间: 2010年3月26日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
12

研究概览

简要总结

All patients achieved the planned 45 gray of radiation therapy There was no grade 3 toxicity The recommended dose of S-1 was determined to be 80 mg/day The dose intensity of S-1 was well maintained and the combination of S-1 plus radiation therapy was well tolerated by all patients Sphincter preserving procedures were possible in all but one (89%) patient High rates of tumor shrinkage and nodular downstaging were achieved The histological response rate was 78% including one complete response

研究设计

研究类型
Interventional

入排标准

年龄范围
20years-old 至 80years-old(—)
性别
All

入选标准

  • 未提供

排除标准

  • 1.Impossible to receive TS-1 contained chemotherapy 2.Recieving the radiation therapy in a pelvis 3.Infection 4.Serious complications 5.Myocardial infarction within the last 6 months, previous serious medical illness or allergy for drug 6.Multiple malignancies 7. Pleural effusion or ascites requiring 8.Current or previous Brain metastasis 9.Diarrhea(watery stool) 10.Fresh bleeding of digestive organs 11.Need to treatment with flucytosine, atazanavir sulfate, or warfalin 12.Evidence of psychiatric disability interfering with enrollment to clinical trial 13.Pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant 14.Man of wanting child 15.Need Systemically administration of corticosteroids 16.Patients judged inappropriate for this study by the physicians

研究者

发起方
Toho University School of Medicine

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