Randomized Phase II Study Comparing 2 versus 3 Cycles of Neo-adjuvant Chemotherapy (Docetaxel+CDDP+5FU) for Patients with Resectable Advanced Esophageal Cancer

Randomized Phase II Study Comparing 2 versus 3 Cycles of Neo-adjuvant Chemotherapy (Docetaxel+CDDP+5FU) for Patients with Resectable Advanced Esophageal Cancer - 2 versus 3 Cycle of Neo-adjuvant Chemotherapy for Esophageal Cancer

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015788

Enrollment

180

Registered

2014-12-01

Start date

2014-06-26

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

Resectable Advanced Esophageal Cancer

Interventions

2 cycles of neo-adjuvant chemotherapy (Docetaxel+CDDP+5FU) 3 cycles of neo-adjuvant chemotherapy (Docetaxel+CDDP+5FU)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)histologically-proven thoracic esophageal squamous cell carcinoma with no prior treatment 2)cT1-4a with no distant metastases (UICC stageIB-IV)(including cases with metastases of supraclavicularlymph nodes) 3)age of 20 and older 4)ECOG Performance status 0-2 5)no prior treatment for esophageal cancer 6)normal function of primary organs blood WBC 3000-12000/mm3 neotrophil >1500/mm3 platelet 100,000/mm3 hemoglobin >9g/dl liver T-bil <1.5mg/dl kidney CCr>60 (eitherCockcroft-Gault or actual measurement value) lung room air Sop2>95 7)operable case via thoracotomy and laparotomy 8)cases with informed consent

Exclusion criteria

Exclusion criteria: 1)inoperable case due to dysfunction of primary organs (brain, heart, lung, liver, kidney) 2)cases with active double cancer 3)cases with serious drug sensitivity and its history 4)female during pregnancy or lactation 5)inappropriate cases determined by primary doctor 6)cases with mental disorder enough to be unable to understand context of the present study 7)cases who have underwent cisplatin-based chemotherapy 8)cases with positivity of HBs antigen

Design outcomes

Primary

Measure	Time frame
2-year progression-free survival	—

Countries

Japan

Contacts

Public ContactOsamu Shiraishi

Department of surgery, Kindai univerisity Department of upper GI surgery

shiro@surg.med.kindai.ac.jp072-366-0221

Outcome results

None listed

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