JCOG2203: A randomized controlled phase II/III trial of neoadjuvant chemotherapy for Japanese patients with esophagogastric junction adenocarcinoma

Phase 2

Recruiting

• Conditions: Esophagogastric junction adenocarcinoma

• Registration Number: JPRN-jRCTs031230182
• Lead Sponsor: KUROKAWA Yukinori

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 460

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
(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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified