Efficacy and safety of neoadjuvant chemotherapy by S-1 plus cisplatin for Stage III esophageal squamous cell carcinoma: A phase II trial

Phase 2

• Conditions: Esophageal squamous cell carcinoma

• Registration Number: JPRN-UMIN000014707
• Lead Sponsor: agoya University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ 2) Uncontrolled infection 3) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers 4) Psychiatric disease 5) Continuous systemic steroid therapy 6) Uncontrolled severe complications (DM, hypertension, diarrhea, et al.) 7) Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated 8) Symptomatic CNS metastasis 9) Interstitial lung disease or pulmonary fibrosis 10) Hypersensitivity for S-1 or cisplatin 11) Flucytosine, phenytoin, warfarin potassium or aminoglycoside antibiotic administration 12) Intestinal bleeding 13) Judged by physician inadequate for inclusion in this trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate

Secondary Outcome Measures

Name	Time	Method
Adverse event, 2 year survival rate, Progression free survival, Relative dose intensity, Pathological response