Phase I trial of Nedaplatin+5FU+Doc combination therapy for Recurrence or Metastatic of Esophagus cancer - Phase I trial of Nedaplatin+5FU+Doc combination therapy for Recurrence or Metastatic of Esophagus cancer

Kinki University School of Medicine0 个研究点目标入组 18 人开始时间: 2010年8月6日最近更新: 2023年10月17日

适应症

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•1) During treatment or diabetes mellitus inadequate control (HbA1c merges) doing more than 6.5% with an aim by consecutive use of insulin. 2) The patient having active multiple primary cancer (synchronism multiple primary cancer and a having sound health period, metachronous multiple primary cancer within five years). But healing and judged carcinoma in situ (carcinoma in situ) or lesion of intramucosal carcinoma equivalency cannot include.In active multiple primary cancer by local treatment. 3) It is the patient having an anaphylactic history for DOC, CDGP, 5-FU and polysorbate "80" component pharmaceutical. 4) We have active bacteria and fungal infection. (we have pyrexia more than 38 degrees Celsius, and bacterial infection is proved on an imaging or bacteriologic examination) 5) The patient who has consecutive systemic therapy (in internal use or a vein) of steroid. 6) Regardless of presence of a cause, it is motor paralysis, the patient having peripheral neuropathy (more than CTCAE v3.0, Grade 1). 7) The patient who shows dropsy (more than CTCAE v3.0, Grade 1) regardless of presence of cause. 8) The patient having the interstitial pneumonia that is apparent by chest X-rays or CT or pulmonary fibrosis. 9) The patient whom we merge psychosis or neurologic manifestation, and it is judged to have difficulty with participation to an examination. 10) During the pregnancy or a pregnant female patient we are possible or are nursing.

发起方

Kinki University School of Medicine