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Phase II Trial of neoadjuvant chemotherapy with docetaxel, cisplatin and 5-FU for advanced esophageal cancer

Phase II Trial of neoadjuvant chemotherapy with docetaxel, cisplatin and 5-FU for advanced esophageal cancer - Phase II Trial of neoadjuvant chemotherapy with DCF for esophageal cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000007408
Enrollment
40
Registered
2012-02-29
Start date
2011-06-01
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

Chemotherapy using docetaxel+Cisplatin+5-FU Surgical resection

Sponsors

Second Department of Surgery, Wakayama Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients who are going to undergo curative esophagectomy with 2F or 3F lymph node dissection 2)TNM stage II/III 3)ECOG performance status 0-1 4)20 years and older, 75 years and younger 5)Patients must have histologic confirmation of the diagnosis with tumor 6)Patients have not received prior chemotherapy nor chemoradiotherapy 7)Laboratory values as follows; 3000/mm3 < WBC < 12000/mm3 1500/mm3 < granulocyte count 8.0 gm/dl < hemoglobin Platelet count > 100000/mm3 Aspartate transaminase < 150 IU/L Alanine transaminase < 150 IU/L Creatinine < 1.5 mg/dl 8)Able and willing to give valid written informed consent

Exclusion criteria

Exclusion criteria: Different histological type from squamous cell carcinoma or adenocarcinoma Patient with allergic response to anticancer drugs (docetaxel, cisplatin, 5-FU) Active or uncontrolled infection Pregnancy (women of childbearing potential: refusal or inability to use effective means of contraception) Clinically significant heart disease Patients with a history of myocardial infarction within the previous three months Patients with uncontrolled diabetes mellitus or hypertension Patients with interstitial pneumonia or pulmonary fibrosis Patients who receive hemodialysis Presence of clinically apparent central nervous system metastases Patients with any other severe concurrent disease, which in the judgment of the investigator, would make the patient inappropriate for entry into this study Decision of unsuitableness by principal investigator or physician-in-charge

Design outcomes

Primary

MeasureTime frame
Pathological response

Secondary

MeasureTime frame
Curative resection rate Clinical response of chemotherapy Postoperative complication 2y survival rate 3y survival rate

Countries

Japan

Contacts

Public ContactMakoto Iwahashi

Wakayama Medical University Second Department of Surgery

makoto@wakayama-med.ac.jp

Outcome results

None listed

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