Phase I/II study of bi-weekly docetaxel and cisplatin plus S-1 (bi-weekly DCS) as first-line therapy for advanced esophageal cancer.

Not Applicable

Recruiting

• Conditions: Esophageal cancer

• Registration Number: JPRN-UMIN000032257
• Lead Sponsor: The University of Tokyo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-16
• Last Update Posted: 17 October 2023
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

1)Synchronous or metachronous (within 5 years) double cancers, except for intoramucosal tumor curatively resected by local therapy 2)With active systemic infection disease 3)With active hepatitis B or C 4)With HIV infection 5)With a history of interstitial pneumonia, pulmonary fibrosis or irradiation pneumonitis 6)Severe psychological illness. 7)With continuous systemic steroid or immune-suppressive drug therapy. 8)Poorly controlled diabetes mellitus or thyroid diseases. 9)Unstable angina within 3 weeks or with a history of acute myocardial infarction within 3months 10)With history of hypersensitivity to docetaxel, cisplatin or polysorbate 80-containing formulations 11)Pregnant and/or nursing women or men who wish to have children in future 12)Judged to be unfit to participate in this study by investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PhaseI part: DLT PhaseII part:PFS

Secondary Outcome Measures

Name	Time	Method
PhaseI part: Adverse Event PhaseII part: Overall survival(OS), Response rate(RR), Adverse Event, Quality of life(QOL)