A phase II study of neoadjuvant chemotherapy with S-1 and oxaliplatin followed by surgery in cStage III advanced gastric cancer patients

Phase 2

• Conditions: Gastric cancer

• Registration Number: JPRN-jRCTs051180020
• Lead Sponsor: Hayata Keiji

Brief Summary

This study suggestedthat the preoperative SOX regimen wasa tolerable regimen, howeverthe target number of cases could not be accumulated and the results were not obtained with the reliability intended at the time of study planning.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-28
• Study Completion: 2021-04-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1) Histologically proven gastric
adenocarcinoma
2) Clinical Stage III gastric cancer. No peritoneal metastases corresponding to P1. No distant metastasis including liver metastasis or the paraaortic lymph node metastasis
3) Age between 20 and 80 years old
4) ECOG performance status of 0 or 1
5) No previous chemotherapy,radiation
therapy or surgery for gastric cancer
6) Adequate organ function
(1) WBC:>=3,000/mm3,<12,000/mm3
(2) Neutrophil:>=1,500/mm3
(3) Platelet:>=100,000/mm3
(4) Hemoglobin:>=9,0g/dL
(5)AST(GOT)/ALT(GPT):<=100 IU/L
(6)Total bilirubin:<=2,0mg/dL
(7)Serum creatinine:<=1,2mg
(8)Creatinine clearance:>=60 mL/min
7)Possible oral intake
8) Written informed consent from patient

Exclusion Criteria

1) With active double or multiple cancers
2) Severe complications (such as intestinal paralysis, bowel obstruction, interstitial pneumonia, pulmonary fibrosis, uncontrolled diabetes mellitus, uncontrolled hypertension, heart failure, renal failure, cirrhosis, hepatic failure)
3) With active infection
4) Positive HBs antigen or positive HCV
antibody
5) Continuous systemic steroid therapy
6) Severe diarrhea
7) Past history of severe hypersensitivity to drugs
8) Under treatment with flucytosine
9) Under treatment with warfarin
10) Pregnant women, or women with the
possibility of the pregnancy, Men who want let to pregnancy
11) Patients judged inappropriate for the study by the physicians

Study & Design

• Study Type: Interventional
• Study Design: Not specified