NIPH Clinical Trials Search

JRCT ID: jRCTs041190129

Registered date:16/03/2020

A feasibility study of neoadjuvant docetaxel+cisplatin+fluorouracil (DCF) with pegfilgrastim on day3 for patients with esophageal cancer

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedEsophageal cancer
Date of first enrollment16/03/2020
Target sample size35
Countries of recruitment
Study typeInterventional
Intervention(s)Docetaxel 70mg/m2 day1 Cisplatin 70mg/m2 day1 Fluorouracil 750mg/m2/day days1-5 Pegfilgrastim 3.6mg day3 3 courses every 3 weeks


Primary OutcomeRate of febrile neutropenia
Secondary OutcomeRate of Grade 3 or higher neutropenia, curative resection rate, response rate of preoperative treatment, histopathological response rate, histopathological complete response rate, rate of adverse events during preoperative therapy, rate of incidence of perioperative complications, late complication rate, serious adverse event rate, progression-free survival, and overall survival

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 75age old
Include criteria1.ECOG PS 0-1 2.Endoscopic biopsy of esophageal primary lesion histologically diagnosed as squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma or basal cell carcinoma. 3. Any of the following based on TNM classification (UICC-TNM 7 th edition) 1) cStage IB 2) cStage II 3) cStage III Infiltration into the trachea at the cervical /cervical chest boundary (T4) is eligible. Excluding other T4. So-called borderline-resectable T4 disease, not clearly diagnosed as T4, is eligible. 4) cStage IV with supraclavicular lymph node metastasis and without other distant metastasis. 4. Adequate organ function.
Exclude criteria1) Clear T4 other than invasion of cervical / cervical gastrointestinal tract esophageal cancer 2) Distant metastasis to other than supraclavicular lymph nodes. 3) Esophagogastric junction lesion of which main lesion is located in the stomach rather than the esophagus. 4) Judged not to be eligible by the researchers

Related Information


Public contact
Name Osamu Maeda
Address 65 Tsurumai-cho Showa-ku Nagoya Aichi Prefecture Aichi Japan 466-8560
Telephone +81-52-744-1903
Affiliation Nagoya University
Scientific contact
Name Osamu Maeda
Address 65 Tsurumai-cho Showa-ku Nagoya Aichi Prefecture Aichi Japan 466-8550
Telephone +81-52-744-1903
Affiliation Nagoya University