Phase 1/2 Study of Docetaxel, CDDP and 5-FU therapy in Patients With Unresectable or Recurrent Esophageal Cancer

Phase 1/2 Study of Docetaxel, CDDP and 5-FU therapy in Patients With Unresectable or Recurrent Esophageal Cancer - Phase 1/2 Study of Docetaxel, CDDP and 5-FU therapy in Patients With Unresectable or Recurrent Esophageal Cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003633

Enrollment

Registered

2010-05-18

Start date

2008-10-01

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

Unresectable or recurrent esophageal cancer

Interventions

dosage level: In phase I study, the dosege level of Docetaxel(DTX), cisplatin(CDDP) and 5FU shows table below. DTX CDDP 5-FU Level1 60mg/m2 70mg/m2 700mg/m2 Level2 70mg/m2 70mg/m2

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed squamous cell carcinoma of esophagus. 2. clinically confirmed T4 tumor and/or M1 LYM or M1 according to the Tumor-Node-Metastasis classification of the UICC, or recurrent esophageal carcinoma after radical esophagectomy 3. There is at least one estimative lesion. 4. Patients have never received chemotherapy and/or radiotherapy for esophageal cancer. 5. Patients of age =>20 and 75=> at the registration. 6. Performance Status:0-2(ECOG) 7. Sufficient organ functions within two weeks before registration. 1) leukocyte >=4,000/mm3 and <=12,000/mm3 2) platelets >=100,000/mm3 3) hemoglobin >=9.0g/dl (and except from administration of blood transfusion) 4) total bilirubin <=1.5mg/dl 5) AST(GOT)/ALT(GPT): within 2 times the upper limit of normal 6) total bilirubin <=1.5 mg/dl 7) creatinine clearance >=60ml/min (following Cockcroft-Gault calculus 8) SpO2 >= 95%(at room air) 8. Written informed consent. 9. It is expected that patients survive for over 3 months.

Exclusion criteria

Exclusion criteria: 1. Patients have serious complications (heart disease, pulmonary fibrosis, interstitial pneumonia, hemorrhagic tendency and so on) 2. active infection 3. active synchronous malignancy 4. peripheral neuropathy or edema >= Grade 2 (CTCAE version3) 5. history of serious drug hypersensitivity 6. brain metastasis 7. pregnant or lactation women, or women with the possibility of the pregnancy and men who want let to pregnancy 8. patients who are judged inappropriate for the entry into study by the investigator

Design outcomes

Primary

Measure	Time frame
Recommended dose Dose limiting toxicity Response rate	—

Secondary

Measure	Time frame
Toxicity Time to progression Overall survival	—

Countries

Japan

Contacts

Public ContactMakoto Yamasaki

Graduate School of Medicine, Osaka University Department of Surgery

myamasaki@gesurg.med.osaka-u.ac.jp06-6879-3251

Outcome results

None listed

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