Feasibility Study of adjuvant chemotherapy of S-1/Oxaliplatin for patients with Stage III gastric cancer patients

Phase 2

• Conditions: Gastric cancer

• Registration Number: JPRN-jRCTs041180052
• Lead Sponsor: Kamiya Kinji

Brief Summary

S-1/oxaliplatin regimen as adjuvant chemotherapy after D2 gastrectomy in stage III gastric cancer treatment seems feasible for outpatients with tolerable toxicities.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-26
• Study Completion: 2020-04-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1) Histological proven gastric cancer
2) Surgical operated by D2 lymphadenectomy and curability A
3) Clinical Stage IIIA, IIIB, IIIC (T2N3, T3N2-3, T4aN1-3, T4bN0-3) according to Japanese Classification of Gastric Cancer 14th edition
4) Age 20-80 years
5) No pretreatment (radiotherapy, chemotherapy, hormone therapy etc.) except surgery
6) Capable of protocol therapy within 56 days after gastrectomy
7) PS (ECOG) 0 or 1
8) Capable oral food uptake
9) Clear to the criteria as below within 14days after registration
-Hemoglobin: > 9.0 g/dL
-Leukocyte: > 3,000 /mm3 < 12,000 /mm3
-Neutrophil: > 1,500 /mm3
-Blood platelet count: > 100,000 /mm3
-Total bilirubin: < 1.5 mg/dL
-AST (GOT), ALT (GPT): < 100 IU/L
-Creatinine clearance: > 60 mL/min
10) Capable to have given written informed consent to participate in this study

Exclusion Criteria

1) Active synchronous metachronous malignancy with longer than 5year interval period without below written cases
-Carcinoma in situ of cervical cancer and focal cancer in adenoma of colorectal cancer
2) Contraindication of S-1 and Oxaliplatin
3) Regular use of flucytosine, phenytoin or warfarin potassium
4) Active infection with over 38 degree fever
5) History of serious drug hypersensitivity
6) Any other serious illness or medical conditions including interstitial paresis, intestinal obstruction, pneumonitis, pulmonary fibrosis, uncontrolled diabetes, renal failure, liver failure
7) HIV positive or active hepatitis
8) Severe diarrhea (over 4 times/day or watery diarrhea)
9) Pregnancy or lactation
10) Male intension that get with child
11) Patients who are recognized as inadequate patients by doctor with responsibility in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment completion rate of up to protocol treatment 5 courses

Secondary Outcome Measures

Name	Time	Method
Adverse events occurrence rate