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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041190129
Enrollment
35
Registered
2020-03-16
Start date
2020-03-16
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal cancer

Interventions

Docetaxel 70mg/m2 day1 Cisplatin 70mg/m2 day1 Fluorouracil 750mg/m2/day days1-5 Pegfilgrastim 3.6mg day3 3 courses every 3 weeks

Sponsors

Maeda Osamu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.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.

Exclusion criteria

Exclusion criteria: 1) 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

Design outcomes

Primary

MeasureTime frame
Rate of febrile neutropenia

Secondary

MeasureTime frame
Rate 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

Contacts

Public ContactOsamu Maeda

Nagoya University

maeda-o@med.nagoya-u.ac.jp+81-52-744-1903

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026