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)

JRCT ID: jRCTs031230231

Registered date:14/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Resectable large type 3 or type 4 gastric cancer
• Date of first enrollment: 31/07/2023
• Target sample size: 76
• Study type: Interventional

Intervention(s)

Arm A: Preoperative chemotherapy with 5-FU, Levofolinate, Oxaliplatin, and Docetaxel (FLOT) followed by surgery with lymph node dissection and postoperative chemotherapy with S-1 or Docetaxel plus S-1 (DS) for one year
Arm B: Preoperative chemotherapy with Docetaxel, Oxaliplatin, and S-1 (DOS) followed by surgery with lymph node dissection and postoperative chemotherapy with S-1 or Docetaxel plus S-1 (DS) for one year

Outcome(s)

• Primary Outcome: A proportion of patients with pathological response >= Grade 1b according to the 15th edition of the Japanese Classification of Gastric Carcinoma (independent central pathological review)
• Secondary Outcome: a proportion of pathological response >= Grade 1b (assessed through an in-house pathological review), adverse events, a proportion of protocol treatment completion, response rate of neoadjuvant chemotherapy according to RECIST ver1.1, pre-and postoperative chemotherapy dose intensity, a proportion of R0 resection, a proportion of major pathological response (MPR), a proportion of patients undergoing postoperative chemotherapy at 3, 6, 9, and 12 months after surgery, progression-free survival, and overall survival

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 79age old
• Gender: Both

Include criteria

(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.

Exclude criteria

(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.

Related Information

• Primary Sponsor: OHASHI Manabu
• Source(s) of Monetary Support: National Cancer Center Japan