JCOG2204: A randomized phase II study to compare the pathological responses of neoadjuvant chemotherapy for type 4 or large type 3 gastric cancer: 5-FU, Oxaliplatin and Docetaxel (FLOT) versus Docetaxel, Oxaliplatin and S-1 (DOS)
- Conditions
- Resectable large type 3 or type 4 gastric cancer
- Registration Number
- JPRN-jRCTs031230231
- Lead Sponsor
- OHASHI Manabu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 76
(1) Pathologically proven adenocarcinoma with endoscopic biopsy specimen.
(2) The macroscopic tumor type is either Borrmann type 4 (linitis plastica) or large (>=8 cm) type 3.
(3) No distant metastasis based on contrast-enhanced thoracic, abdominal, and pelvic CT.
(4) No non-curable factors other than positive lavage cytology (CY1) or peritoneal dissemination localized around the stomach (P1a) were revealed in a staging laparoscopy before registration.
(5) No esophageal invasion or an invasion of less than 2 cm.
(6) No residual stomach cancer.
(7) Ages between 18 and 79 years.
(8) Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
(9) No prior chemotherapy, radiotherapy, or immunotherapy for any malignancies.
(10) No history of any surgical treatment for gastric cancer other than endoscopic mucosal resection.
(11) No obvious hemorrhage nor gastrointestinal obstruction due to the primary tumor.
(12) Sufficient oral intake.
(13) Sufficient organ function as follows:
i) Neutrophil >= 1,500/mm3
ii) Hemoglobin >= 8.0 g/dL
iii) Platelet >= 75,000/mm3
iv) Total bilirubin <= 2.0 mg/dL
v) AST <= 100 IU/L
vi) ALT <= 100 IU/L
vii) Creatinine clearance (CCr) >= 50 mL/min/body
(14) Written informed consent.
(1) Synchronous or metachronous (within 5 years) malignancies except for cancer with a 5-year relative survival rate of >= 95%, such as carcinoma in situ, intramucosal tumor, or early-stage cancers.
(2) Infectious disease that needs systemic treatment.
(3) Body temperature is 38 degrees centigrade or higher at registration.
(4) Females during pregnancy, within 28 days of post parturition, or during lactation, or males who expect a partner's pregnancy.
(5) Severe psychiatric disease affecting daily life.
(6) Receiving continuous systemic corticosteroid or immunosuppressive treatment.
(7) Under flucytosine, phenytoin, or warfarin treatments
(8) History of unstable angina pectoris within 3 weeks or myocardial infarction within 6 months before registration.
(9) Uncontrollable valvular heart disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.
(10) Uncontrollable hypertension.
(11) Uncontrollable diabetes mellitus.
(12) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema diagnosed by chest CT.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method