Feasibility study of adjuvant therapy with S-1 plus CDDP in gastric cancer

Not Applicable

• Conditions: Gastric cancer

• Registration Number: JPRN-UMIN000000920
• Lead Sponsor: ational Cancer Center Hospital

Brief Summary

A total of 63 enrolled patients have been evaluated. Grade 3/4 toxicities included neutropenia (40%), anorexia (28%), and febrile neutropenia (4%) before protocol amendment (n = 25), and neutropenia (37%), anorexia (8%), and febrile neutropenia (3%) after amendment implementation (n = 38). Excluding ineligible cases, treatment completion rates were 57% (12/21) before and 81% (30/37) after the protocol amendment.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-12-02
• Study Completion: 2010-09-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

Not provided

Exclusion Criteria

1)synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ 2)pregnant or breast-feeding women 3)severe mental disease 4)systemic administration of corticosteroids, flucytosine, phenytoin or warfarin 5)other severe complications, such as paralytic ileus, bowel obstruction, interstitial pneumonitis, pulmonary fibrosis, regular use of insulin or uncontrollable diabetes mellitus, arrhythmias, heart failure, liver cirrhosis, and active hepatitis) 6)myocardial infarction within the past 6 months 7)Inadequate physical condition, as diagnosed by primary physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment compliance with 3 courses of S-1 plus CDDP

Secondary Outcome Measures

Name	Time	Method
Treatment compliance with 2 courses of S-1 plus CDDP, proportion of patients receiving treatment according to protocol, and adverse events