A phase II study of neoadjuvant chemotherapy with docetaxel, cisplatin, and S-1 in advanced esophageal cancer patients with normal oral intake

A phase II study of neoadjuvant chemotherapy with docetaxel, cisplatin, and S-1 in advanced esophageal cancer patients with normal oral intake - A phase II study of neoadjuvant chemotherapy with DCS for esophageal cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000017153

Enrollment

Registered

2015-04-16

Start date

2014-07-01

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+S-1 followed by surgicalresection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients must have historogic confirmation of squamous cell carcinoma or adenocarcinoma or basaloid carcinoma by endoscopic biopsy (2) TMN stage IB/II/III (3) 20 years and older, 75 years and younger (4) ECOG performance status 0-1 (5) Patients have not received prior chemotherapy or radiotherapy (6) Patients who are going to under curative esophagectomy (R0) (7) Patients with normal oral intake (8) Lavoratory values as fellows; 4000 < WBC < 12000/mm3 granulocyte count > 2000/mm3 Hemoglobin > 8.0 g/dL Platelet count > 100,000/mm3 AST, ALT < 100 IU/L T-bil < 1.5 mg/dL Cr < 1.2 mg/dL Ccr > 60 mL/min/body

Exclusion criteria

Exclusion criteria: (1)Patients with concurrent other primary cancer requiring treatment (2)Pregnancy, possible pregnancy after delivery or breast feeding (3)Patients requiring systemic administration of steroid (4)Positive HBs antigen (5)Patients requiring flucytosine or phenytoin or warfarine administration (6)Patients for allergy of iodine (7)Patient with allergic response to anticancer drugs (docetaxel, cisplatin, S-1) (8)Severe peripheral nerve disorder (9)Patients with interstitial pneumonia or pulmonary fibrosis (10)Active infection (11)Patients with a history of myocardial infarction or unstable angina pectoris within the previous six months (12)Patients with uncontrolled hypertension or diabetes melitus

Design outcomes

Primary

Measure	Time frame
Pathologocal response	—

Secondary

Measure	Time frame
Curative resection rate Clinical response of chemotherapy Toxicities of chemotherapy Postoperative complication 2y survival rate 3y survival rate	—

Countries

Japan

Contacts

Public ContactMikihito Nakamori

Wakayama Medical University Second Department of Surgery

chamcham@wakayama-med.ac.jp073-441-0613

Outcome results

None listed

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