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

JRCT ID: jRCTs051180020

Registered date:28/12/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Gastric cancer
• Date of first enrollment: 07/06/2016
• Target sample size: 48
• Study type: Interventional
• Intervention(s): S-1:80-120mg/body/day,PO,day1-14,Oxaliplatin130 mg/m2, IV day1, every 21 days for 3 cycles followed by surgery (laparoscopic or open gastrectomy, D2 lymph node dissection).Adjuvant chemotherapy(S-1) for one year after surgery.

Outcome(s)

• Primary Outcome: Percent completion of the protocol treatment
• Secondary Outcome: Overall survival, Relapse-Free Survival, Time to Treatment Failure, Percent completion of neoadjuvant chemotherapy, Percent completion of adjuvant chemotherapy, Response Rate, Pathological response rate, Incidence of adverse events on neoadjuvant chemotherapy, Incidence of a postoperative complication, The rate of R0 resection, Percent completion of the protocol treatment in patients with over 75 years of age

Key inclusion & exclusion criteria

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

Include 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

Exclude 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

Related Information

• Primary Sponsor: Hayata Keiji
• Secondary ID(s): UMIN000023405