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Phase II trial of neoadjuvant docetaxel + cisplatin + fluorouracil (DCF) therapy for esophageal cancer

Phase II trial of neoadjuvant docetaxel + cisplatin + fluorouracil (DCF) therapy for esophageal cancer - Phase II trial of neoadjuvant docetaxel + cisplatin + fluorouracil (DCF) therapy for esophageal cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000028252
Enrollment
28
Registered
2017-08-01
Start date
2017-08-01
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 70 mg / m2 day 1 Cisplatin 70 mg / m2 day 1 Fluorouracil 750 mg / m2 / day days 1 - 5 Three courses every 3 weeks above Followed by esophagectomy + D 2 or more lymph node dissection

Sponsors

Nagoya University
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
Histopathological response rate

Secondary

MeasureTime frame
Curative resection rate, response rate in preoperative therapy, histopathological complete response rate, rate of adverse events during preoperative therapy, rate of perioperative complications, rate of late complications, rate of serious adverse events, progression-free survival, and overall survival

Countries

Japan

Contacts

Public ContactOsamu Maeda

Nagoya University Hospital Department of Clinical Oncology and Chemotherapy

maeda-o@med.nagoya-u.ac.jp052-741-2111

Outcome results

None listed

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