Phase II study of S-1 and oxaliplatin as neoadjuvant chemotherapy for locally advanced adenocarcinoma of the gastric or esophagogastric junction(KSCC1601)

JRCT ID: jRCTs071180064

Registered date:20/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Gastric cancer/Esophagogastric junction cancer
• Date of first enrollment: 06/06/2016
• Target sample size: 46
• Study type: Interventional

Intervention(s)

Oxaliplatin 130 mg/m2, IV day 1 ,
S-1 80-120 mg/m2/day, PO days 1-14,
every 21 days for 3 cycles followed by
surgery

Outcome(s)

• Primary Outcome: pathological response rate: pRR

Secondary Outcome

Anastomotic leakage of tumours are classified as Siewert Type II and Type III
Overall survival
Complete resection rate, resection rate
Relapse free survival
Response rate
Adverse events
Surgical complecations

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) The individual consents in writing to receipt of the protocol treatment
2) A lead investigator deems that the patient can be treated with the protocol (the patient is suitable for enrollment)
3) A common type of gastric adenocarcinoma (include Siewert Type III): T 3/4a/4b, N 1/2/3a/3b, esophagogastric junction adenocarcinoma classified as Siewert Type II: T 3/4a/4b, N 0/1/2/3a/3b
4) Enhanced thoracic/ abdominal/ pelvic CT revealed having none of the followings:
i) Lung metastasis
ii) Peritoneal metastasis
iii) Liver metastasis
iv) Pleural effusion, ascites
v) Distal lymph nodes metastasis
vi) Other distant metastasis
5) Clinically no sign of cervical lymph node nor distant metastasis
6) No liver metastasis and peritoneal metastasis, CY0 by laparoscopy
7) Not a remnant gastric cancer
8) No prior treatment of chemotherapy or radiation therapy or endocrine therapy against any other malignancies
9) No prior surgery for esophagogastric junction cancer and gastric cancer except for endoscopic resection
10) Age upon enrollment is over 20 years
11) Performance Status (ECOG) 0 or 1
12) The patient is readily able to take medication orally
13) The patient has no severe dysfunction of major organs (bone marrow, liver, kidneys, heart, lungs, etc.) and the patient's laboratory results from up to 14 days prior to enrollment fall within the criteria
i) WBC <=12,000/mm3
ii) Neutrophil >=1,500/mm3
iii) Platelet >=100,000/mm3
iv) Hemoglobin >=8.0g/dL
v) Total bilirubin <=1.5mg/dL
vi) AST,ALT <=100IU/L
vii) Albumin >=2.5g/dL
viii) Serum creatinine <=1.5mg/dL
ix) Creatinine clearance >=60mL/min

Exclude criteria

1) Severe drug hypersensitivity (particularly to platinum analogs, 5-FU, or S-1)
2) Peripheral neuropathy affecting the sensory nerves (Grade 1 or worse)
3) Active infection
4) Uncontrollable hypertension
5) Uncontrollable diabetes mellitus or routine administration of insulin
6) Heart disease that may pose a problem
7) Severe pulmonary disease
8) Severe mental disease
9) Active gastrointestinal tract bleeding requiring repeated transfusions
10) Under treatment with phenytoin, warfarin or flucytosine
11) Watery diarrhea (Grade 2 or worse)
12) Synchronous or metachronous malignancies other than carcinoma in situ or mucosal cancer
13) A woman who is pregnant, nursing, or possibly pregnant or a man who is trying to conceive with a partner
14) Cirrhosis or hepatitis
15) Patients judged by the investigator as unfit to be enrolled in the study

Related Information

• Primary Sponsor: Oki Eiji
• Source(s) of Monetary Support: Yakult Honsha Co., Ltd
• Secondary ID(s): UMIN000021061