JCOG1704:A phase II study of preoperative chemotherapy with DOC in advanced gastric cancer
- Conditions
- Gastric cancer
- Registration Number
- JPRN-jRCTs031180028
- Lead Sponsor
- Doki Yuichiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
1) Histologically proven gastric adenocarcinoma
2) HER2 negative has to be confirmed
3) Enhanced abdominal CT revealed having any of the followings:
i) Paraaortic lymph node metastasis (No.16a2/ 16b1)
ii) Bulky lymph node (>=3cmx1 or >=1.5cmx2)
iii) Both of No.16a2/ 16b1 and Bulky lymph node
4) Enhanced thoracic/ abdominal/ pelvic CT revealed having no distant metastasis other than No.13 or No.16a2/ 16b1 lymph node metastasis
5) Neither Borrmann type 4 nor large (8cm or more) type 3
6) Length of esophageal invasion less or equal to 3cm
7) Not stump cancer of stomach
8) Clinically no sign of distant metastasis
9) Age between 20 and 75 at registration
10) Performance Status(ECOG) 0 or 1.
11) No peritoneal metastasis and CY0 by laparoscopy or laparotomy
12) Total gastrectomy with thoracotomy, left upper abdominal exenteration or Appleby's operation is not required to achieve the R0 resection
13) No prior treatment of chemotherapy or radiation therapy or endocrine therapy against any other malignancies
14) 1No prior surgery for gastric carcinoma except for bypass surgery and endoscopic resection
15) Fair oral intake with or without bypass surgery
16) Sufficient organ function.
i. Neutrophil >= 2,000/mm3
ii. Hb >= 8.0 g/dL
iii. Platelet >= 100,000/mm3
iv. T.Bil <= 1.5 mg/dL
v. AST <= 100 IU/L
vi. ALT <= 100 IU/L
vii. CCr >= 50mL/min/body
17) Written informed consent from patient.
1) Synchronous or metachronous (within 5 years) malignancies.
2) Infectious disease requiring systemic treatment.
3) Body temperature of 38 degrees Celsius or higher.
4) During pregnancy, within 28 days of postparturition, or during lactation.
5) Severe mental disease.
6) Receiving continuous systemic corticosteroid or immunosuppressant treatment.
7) Under treatment with flucytosine, phenytoin, or warfarin.
8) History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration.
9) Poorly controlled valve disease, dilated or hypertrophic cardiomyopathy
10) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema based on chest CT
11) Poorly controlled diabetes
12) Poorly controlled hypertension
13) HBs antigen positive
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathological response rate
- Secondary Outcome Measures
Name Time Method overall survival, progression-free survival in patients with R0 resection, proportion of R0 resection, response rate of preoperative chemotherapy by RECIST ver1.0, proportion of completion of surgery, proportion of completion of protocol treatment, toxicities