Esophagogastric junction adenocarcinoma
Conditions
Interventions
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 ch
Sponsors
KUROKAWA Yukinori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (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 = 50 mL/min viii) SpO2 >= 95%(room air) (13) Written informed consent from patient
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase II: Pathological response rate(>= Grade 2) Phase III: Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactYukinori KUROKAWA
The University of Osaka Hospital
Outcome results
None listed