Randomized controlled trial of the efficacy of supportive care during adjuvant chemotherapy
- Conditions
- Gastric cancergastric canceradjuvant chemotherapy
- Registration Number
- JPRN-jRCTs051210007
- Lead Sponsor
- Motoori Masaaki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of patients without dose reduction of S1 or with one-level dose reduction of S1 for one one year
- Secondary Outcome Measures
Name Time Method Actual total prescription dose / planned total dose ratio of S1 or Docetaxel; adverse events of chemotherapy; QOL; body composition; muscle strength; nutritional parameter; intestinal environment