JPRN-jRCTs051210007
Active, not recruiting
Phase 2
Randomized controlled trial of the efficacy of supportive care during adjuvant chemotherapy in patients with gastric cancer - ACCORD
Motoori Masaaki0 sites150 target enrollmentApril 15, 2021
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Gastric cancer
- Sponsor
- Motoori Masaaki
- Enrollment
- 150
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients with primary gastric cancer between the ages of 20 and 80 who underwent curative gastr
- •ectomy and scheduled to receive adjuvant chemotherapy with S1 or S1 plus docetaxel
- •2\. PS(ECOG) 0\-1
- •3\. White blood cells \> lower limit of normal (LLN) or 4000/mm3 and \< 12000/mm3
- •4\.Neutrophils \>1500/mm3
- •5\.Hemoglobin\>8\.0g/dL
- •6\.Aspartate aminotransferase (glutamic\-oxaloacetic transaminase) (AST(GOT)) and alanine aminotransferase (glutamic\-pyruvic transaminase) (ALT(GPT)) \<3\.0 x upper limit of normal (ULN) of the study site
- •7\.Total bilirubin \<1\.5mg/dL
- •8\.Creatinine \<1\.2mg/dL
- •9\.Creatinine clearance\>60 mL/min
Exclusion Criteria
- •1\. Patients with a history of intestinal resection other than gastrectomy, hepatectomy, or pancreatic resection
- •2\. Patients with simultaneous or metachronous cancer
- •3\. Patients with serious postoperative complications
- •4\. Patients with serious comorbidities, such as interstitial pneumonia, pulmonary fibrosis, uncontrolled diabetes, heart failure, renal failure, and liver cirrhosis
- •5\. Patients receiving systemic administration of steroids
- •6\. Patients taking flucytosine
- •7\. Patients taking warfarin potassium
Outcomes
Primary Outcomes
Not specified
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