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

JRCT ID: jRCTs041180052

Registered date:26/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Gastric cancer
• Date of first enrollment: 27/07/2016
• Target sample size: 25
• Study type: Interventional

Intervention(s)

1 cycle
S-1: 80 - 120 mg/day

2-4 cycle
S-1: 80 - 120 mg/day
S-1 was given orally daily 2 weeks of 3week-cycle
Oxaliplatin: 100 mg/m2 was administered first cycle of 3 week-cycle as same schedule of S-1

Outcome(s)

• Primary Outcome: Treatment completion rate of up to protocol treatment 5 courses
• Secondary Outcome: Adverse events occurrence rate

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kamiya Kinji
• Secondary ID(s): UMIN000023261