PhaseI/II study of Docetaxel/S-1 with radiation for unresectable and/or recurrent esophageal cancer

PhaseI/II study of Docetaxel/S-1 with radiation for unresectable and/or recurrent esophageal cancer - SP vs DS

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004349

Enrollment

Registered

2010-11-01

Start date

2010-12-01

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

unresectyable esophageal cancer, recurrent esophageal cancer

Interventions

Patients were given S-1 (60mg/m2/day) orally from days 1 to 14, and Docetaxel (20 mg/m2 ) intravenously on days 1 and 8. Patients received radiation in 2.0 Gy daily fractions from days 1 to 21, for a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.The patients must have histologically proven squamous cell carcinoma of the esophagus. 2.The tumor is T4 and/or M1 LYM without other organ metastasis or recurrent cancer. 3.The tumor has a measurable lesion for evaluation. 4.No previous treatment or more 4 weeks passed before previous treatment 5.All areas of the disease can be encompassed in the radiation port. 6.The patient's performance status is 0 to 1. 7.The patient's age is 18- 80 years. 8. Adequate organ function 9.WBC count is 4,000/mm3 or more and neutrophil count is 2000 /mm3 or more Platelet count is 100,000/mm3 or more Hemoglobin is 9.5 g/dl or more AST and ALT levels are within twice the normal upper limits Serum bilirubin level is 1.5 mg/dl or less Serum creatinin levels are 1.5 mg/dl or less 10.Life expectancy expectd more than 12 weeks 11. Written informed consent

Exclusion criteria

Exclusion criteria: Excluded criteria is follow; 1.the case complicated severe heart failure,liver chirrhosis, uncontrolled diabets, interstitial pneumonia or fibriod lung, pooling of pleural effusion needed treatment and pericardial effusion. 2.the case suspected of infection with feaveer 3.the case had the motion disturbance, peripheral nerve palsy and severe edema 4.the case complicated other active cancer 5.pregnant woman or lactational woman

Design outcomes

Primary

Measure	Time frame
overall response	—

Secondary

Measure	Time frame
Overall suevivalsurvival Time to progression toxicity Local conterol rate	—

Countries

Japan

Contacts

Public ContactHideo Matsumoto

Kawasaki Medical University Department of Digestive Surgery

h-mastu@med.kawasaki-m.ac.jp086-462-1111

Outcome results

None listed

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