KSCC1801

JRCT ID: jRCTs071180001

Registered date:27/06/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Gastric cancer
• Date of first enrollment: 19/10/2018
• Target sample size: 25
• Study type: Interventional

Intervention(s)

Oxaliplatin 130 mg/m2, IV day 1 ,
S-1 80-120 mg/ day or 50-100 mg/m2/day, PO days 1-14, every 21 days for 3 cycles followed by curative surgery.

Outcome(s)

• Primary Outcome: Dose intensity

Secondary Outcome

Relative dose intensity of preoperative SOX therapy
Protocol treatment completion rate
Completion rate of SOX 3 courses + curative surgery
Completion rate of 3 courses of preoperative chemotherapy
Response rate of preoperative chemotherapy
Rate of occurrence of adverse events
Rate of occurrence of surgical complications
Pathological response rate
R0 Resection rate
Overall survival (OS)
Relapse Free Survival (RFS)

Key inclusion & exclusion criteria

• Age minimum: >= 70age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)The individual consents in writing to receipt of the protocol treatment.
2)The cancer is histologically confirmed (via biopsied tissue) to be an adenocarcinoma.
3)The tumor is diagnosed with cT3-4 by imaging findings.
4)Enhanced upper abdominal CT revealed having gastric regional lymph nodes swelling with greater than 8mm in minor axis diameter or 10mm in major axis diameter (N1-3).
5)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
6) Clinically no sign of cervical lymph node nor distant metastasis.
7) No liver metastasis and peritoneal metastasis, CY0 by laparoscopy.
8) Not a remnant gastric cancer.
9) The patient can have oral intake.
10) No prior chemotherapy or radiation therapy or endocrine therapy against any other malignancies within 5 years.
11) 70 years of age or older
12) Performance Status (ECOG) 0 or 1
13) The patient's laboratory results from up to 14 days prior to enrollment fall within the criteria
i) Neutrophil >=1,500/mm3
ii) Hemoglobin >=8.0g/dL
iii) Platelet >=100,000/mm3
iv) Total bilirubin <=1.5mg/dL
v) AST <=100IU/L
vi) ALT <=100IU/L
vii) Creatinine clearance >=40mL/min

Exclude criteria

1) 3cm or greater in distance of esophageal invasion
2) Type 4 gastric cancer macroscopically involving whole stomach
3) Severe drug hypersensitivity (particularly to platinum analogs, 5-FU, or S-1)
4) Peripheral neuropathy affecting the sensory nerves (Grade 1 or worse)
5) Active infection
6) Uncontrollable hypertension
7) Uncontrollable diabetes mellitus
8) Heart disease that may pose a problem
9) Severe pulmonary disease
10) Severe mental disease
11) Active gastrointestinal tract bleeding requiring repeated transfusions
12) Under treatment with phenytoin, warfarin or flucytosine
13) Watery diarrhea (Grade 2 or worse)
14) Synchronous or metachronous active malignancies
15) A man who is trying to conceive with a partner
16) Cirrhosis or active hepatitis
17) Patients judged by the investigator as unfit to be enrolled in the study.

Related Information

• Primary Sponsor: Saeki Hiroshi

Source(s) of Monetary Support

YakultHonsha Co.,Ltd.
Clinical Research Support Center Kyushu