Comparison of multimodality treatment: 2 or 4courses of neoadjuvant chemotherapy of S-1/CDDP or S-1/CDDP/Docetaxel folloewd by surgery and adjuvant S-1 chemoterapy for locally advanced gastric cancer, a randomized phase 2 trial

Phase 2

• Conditions: gastric cancer

• Registration Number: JPRN-UMIN000006378
• Lead Sponsor: non-profit organization KSATTS

Brief Summary

Gastrointestinal Cancer Symposium 2019 (ASCO-GI 2019) 2019/1/17 Considering high 3-year OS, four courses DCS has a value to be tested in a future phase III study to confirm superiority of neoadjuvant chemotherapy for locally advanced gastric cancer.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-21
• Study Completion: 2016-09-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

i. Remnant stomach cancer ii. Synchronous or metachronous cancer (synchronous multiple cancers in the stomach included). iii. Females with an on-going pregnancy or breast-feeding, or who are contemplating pregnancy. iv. Mental disorders which may affect the ability or willingness to provide informed consent or abide by the study protocol v. Systemic treatment with a corticosteroid vi. Systemic treatment with flucytosine, phenytoin, or warfarin potassium vii. Allergic reaction to iodine viii. Hypersensitivity to docetaxel, cisplatin, or polysorbate 80 ix. Peripheral neuropathy x. Edema xi. Pneumonitis, lung fibrosis, or emphysema in need for oxygen therapy xii. Active inflammation due to bacteria or fungus xiii. Unstable angina or cardiac infarction within 6 months xiv. Positive for HBs antigen or HCV antibody xv. Unstable hypertension xvi. Diabetes mellitus under treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Three-year overall survival rate

Secondary Outcome Measures

Name	Time	Method
overall survival, progression-free survival, pathological response, clinical response, R0 resection rate, R0R1 resection rate, completion rate of neoadjuvant chemotherapy, incidence of adverse events, and these parameters in each subset