JCOG2203: A randomized controlled phase II/III trial of neoadjuvant chemotherapy for Japanese patients with esophagogastric junction adenocarcinoma (NEO-JPEG)
JCOG2203: A randomized controlled phase II/III trial of neoadjuvant chemotherapy for Japanese patients with esophagogastric junction adenocarcinoma (NEO-JPEG)
KUROKAWA Yukinori
Osaka University Hospital
2-15, Yamadaoka, Suita, Osaka 565-0871 Japan
+81-6-6879-5111
ykurokawa@gesurg.med.osaka-u.ac.jp
KUROKAWA Yukinori
Osaka University Hospital
2-15, Yamadaoka, Suita, Osaka 565-0871 Japan
+81-6-6879-5111
ykurokawa@gesurg.med.osaka-u.ac.jp
Recruiting
June. 27, 2023
July. 05, 2023
460
Interventional
randomized controlled trial
open(masking not used)
active control
parallel assignment
treatment purpose
(1) Histologically proven esophagogastric junction adenocarcinoma
(2) Esophagogastric junction adenocarcinoma of Siewert type I or type II based on endoscopy
(3) clinical Stage III or IVA (except for T4b) based on the cervical/thoracic/abdominal/pelvic contrast-enhanced CT (UICC-TNM 8th edition)
(4) Neither Borrmann type 4 nor large (8cm or more) type 3. Large type 3 with the center of the tumor located on the esophageal side of the esophago-gastric junction are eligible.
(5) No bulky lymph node metastasis by abdominal contrast-enhanced CT
(6) Judged that R0 resection is possible
(7) Age between 18 and 79 at registration
(8) Performance Status(ECOG) 0 or 1
(9) No prior treatment of endocrine therapy, chemotherapy, molecularly-targeted therapy, and immunotherapy against any other malignancies within 5 years
(10) No prior treatment of radiotherapy to cervical, thoracic, and upper abdominal against any other malignancies
(11) No prior surgery for stomach and esophagus except for the endoscopic resection by EMR/ESD
(12) Sufficient organ function
i) Neutrophil >= 1,500/mm3
ii) Platelet >= 10x10,000/mm3
iii) Hb >= 8.0g/dL
iv) T.Bil <= 1.5 mg/dL
v) AST <= 100 U/L
vi) ALT <= 100 U/L
vii) CCr >= 50 mL/min
viii) SpO2 >= 95%(room air)
(13) 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) Female during pregnancy, within 28 days of postparturition, or during lactation.
(5) Psychological disorder difficult to participate in this clinical study.
(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) Uncontrolled valvular disease, dilated cardiomyopathy, and hypertrophic cardiomyopathy.
(10) Uncontrolled arterial hypertension.
(11) Uncontrolled diabetes mellitus.
(12) Severe emphysema, interstitial pneumonia, or pulmonary fibrosis based on chest CT.
18age old over
79age old under
Both
Esophagogastric junction adenocarcinoma
Arm A: Surgery and lymph node dissection using the approach defined by esophageal invasion length 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 and lymph node dissection using the approach defined by esophageal invasion length, and postoperative chemotherapy with S-1 or Docetaxel plus S-1 (DS) for one year
Arm C: Preoperative chemotherapy with 5-FU, Levofolinate, Oxaliplatin, and Docetaxel (FLOT) followed by surgery and lymph node dissection using the approach defined by esophageal invasion length, and postoperative chemotherapy with S-1 or Docetaxel plus S-1 (DS) for one year
Phase II:response rate of preoperative chemotherapy by RECIST ver1.1, dose intensity of preoperative chemotherapy, pathological complete response rate(Grade 3), proportion of R0 resection, proportion of completion of protocol treatment before surgery, toxicities
Phase III:Progression-free survival, response rate of preoperative chemotherapy by RECIST ver1.0, dose intensity of preoperative chemotherapy, pathological response rate(Grade 3), proportion of R0 resection, proportion of completion of protocol treatment before surgery, proportion of completion of protocol treatment before posoperavie chemotherapy, proportion of patients undergoing postoperative chemotherapy at 3, 6, 9, and 12 months after surgery, toxicities
National Cancer Center Japan
Not applicable
Japan Agency for Medical Research and Development
Not applicable
National Cancer Center Hospital Certified Review Board
