A Phase III Study of Docetaxel/S-1 versus S-1 in the Treatment of Curatively Resected Stage III Gastric Cancer
- Conditions
- Gastric Cancer
- Registration Number
- JPRN-jRCTs041180146
- Lead Sponsor
- KODERA Yasuhiro
- Brief Summary
Postoperative adjuvant therapy with S-1 plus docetaxel was confirmed to improve both RFS and OS and can be recommended as a standard of care for patients with stage III gastric cancer treated by D2 dissection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 951
(1) Patients with a histologically confirmed common type of gastric cancer in pathologic stage IIIA, IIIB, or IIIC
(2) Patients who underwent R0 surgery (i.e., no residual tumor) with D2 lymphadenectomy. However, patients who underwent total gastrectomy without splenectomy (without No. 10 lymph node dissection) will also be eligible.
(3) Patients without any hepatic, peritoneal, or distant metastasis, with negative peritoneal lavage cytology
(4) Patients aged between >=20 years and <=80 years at the time of enrollment
(5) Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score 0 or 1
(6) Patients who underwent surgery for the primary disease within the past 6 weeks (i.e., within 42 postoperative days, with the day of surgery defined as postoperative day 0) and who can take oral medication
(7) Patients without any prior nonsurgical therapy (such as radiotherapy or chemotherapy) for the primary disease
(8) Patients with adequately maintained major organ functions meeting the following criteria based on laboratory tests within 14 days before enrollment
(9) Patients who personally provided written consent to participate in the study
(1) Patients with synchronous or metachronous multiple primary cancers
(2) Patients with serious postoperative complications (e.g., serious postoperative infection, anastomotic leakage, gastrointestinal hemorrhage)
(3) Patients with serious concurrent diseases (e.g., intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, uncontrolled hypertension, cardiac failure, renal failure, hepatic cirrhosis, hepatic failure)
(4) Patients with active infection
(5) Patients positive for HBs antigen or HCV antibody
(6) Patients receiving chronic systemic (oral or intravenous) steroid therapy
(7) Patients with diarrhea (watery stools)
(8) Patients with serious drug allergy
(9) Patients in whom both iodinated agents and gadolinium-based agents cannot be used because of drug allergy
(10) Patients on oral flucytosine
(11) Patients requiring oral warfarin potassium
(12) Pregnant women or women with possible pregnancy, or men who desire pregnancy of their partner
(13) Other patients judged by the investigator or subinvestigator to be inappropriate for participation in this this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method