neoadjuvant docetaxel, oxaliplatin and S-1 therapy for large type 3 or type 4 gastric cancer

JRCT ID: jRCTs051190060

Registered date:11/10/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Gastric cancer
• Date of first enrollment: 15/10/2019
• Target sample size: 46
• Study type: Interventional
• Intervention(s): Preoperative chemotherapy with Docetaxel, Oxaliplatin, and S-1

Outcome(s)

• Primary Outcome: the 3-year progression free survival rate
• Secondary Outcome: progression free survival, overall survival, pathological response rate, response rate, completion rate of neoadjuvant chemotherapy, R0 resection rate, completion rate of surgery, completion rate of protocol treatment, complete response rate of peritoneal cytology (CY), incidence of toxicities, assessment of nutrition

Key inclusion & exclusion criteria

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

Include criteria

1) Histological proven adenocarcinoma
2) Borrmann type 4 or large (8cm or more by Enhanced abdominal CT or gastrointestinal endoscopy) type 3
3) No peritoneal metastasis (CY0 or CY1, and P0) by laparoscopy and CT within 28days.No sign of distant metastasis including liver metastasis or paraaortic lymph node metastasis
4) Length of esophageal invasion less or equal to 3cm by image examination within 28 days
5) Age between 20 and 80 at registration
6) Performance Status(ECOG):0,1
7) No prior treatment of chemotherapy or radiation therapy
8) Adequate organ function
9) Fair oral intake with or without bypass surgery
10) HER2 negative or not examined
11) Written informed consent from patient

Exclude criteria

1) Synchronous or metachronous (within 5 years) malignancies
2) Infectious disease requiring systemic treatment(over 38 degrees Celsius)
3) During pregnancy, postparturition, or during lactation
4) Severe mental disease
5) History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration
6) Receiving continuous systemic corticosteroid or immunosuppressant treatment
7) Under treatment with flucytosine, phenytoin, or warfarin
8) Poorly controlled valve disease, dilated or hypertrophic cardiomyopathy
9) HBs antigen positive
10) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema based on chest CT
11) Poorly controlled hypertension or diabetes
12) Patients judged inappropriate for the study by thephysicians

Related Information

• Primary Sponsor: YAMAGUCHI Toshifumi
• Source(s) of Monetary Support: Yakult Honsha Co.,Ltd.