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Clinical Trials/JPRN-jRCTs051210007
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.

Registry
who.int
Start Date
April 15, 2021
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Motoori Masaaki

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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