JCOG1502C: Japanese trial -A Global Study To Evaluate The Potential Benefit of Adjuvant Chemotherapy for Small Bowel Adenocarcinoma - J-BALLAD

KANEMITSU Yukihide0 个研究点目标入组 115 人开始时间: 2019年1月25日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Histologically proven adenocarcinoma of which primary tumor is located in the duodenum, jejunum, or ileum (adenocarcinoma of the papilla of Vater is ineligible, but primary duodenal adenocarcinoma which histologically invade to the papilla of Vater is eligible).
•2) R0 resection is achieved by small bowel resection, pancreaticoduodenectomy, or distal gastrectomy with regional lymph nodes dissection.
•3) Lavage Cytology during surgery is negative, unknown, or unexamined (Only positive case is ineligible).
•4) Pathological stage is stage I (T1bN0M0 or T2N0M0), stage II, or stage III.
•5) Aged between 16 and 74 years
•6) ECOG performance status (PS) of 0 or 1
•7) Sufficient oral intake
•8) No metastasis/relapse findings on chest CT and enhanced abdomen-pelvis CT/MRI performed within 84 days before registration.
•9) No history of chemotherapy or radiotherapy for small bowel adenocarcinoma.
•10) No history of platinum usage (ex. cisplatin, carboplatin, oxaliplatin, nedaplatin).
•11) From 28 days to 84 days after surgery
•12) Sufficient organ function
•13) Written informed consent

•1) Synchronous or metachronous (within 5 years) malignancies
•2) Active infection requiring systemic therapy.
•3) Body temperature of 38 degrees Celsius or higher.
•4) Female during pregnancy, within 28 days of postparturition, or during lactation.
•5) Severe psychological disease.
•6) Continuous systemic corticosteroid or immunosuppressant treatment.
•7) Inflammatory bowel disease (ex. Crohn disease, ulcerative colitis) or malabsorption (ex. Celiac disease) requiring therapy.
•8) Uncontrollable diabetes mellitus
•9) Uncontrollable hypertension
•10) Unstable angina pectoris, or history of myocardial infarction within 6 months.
•11) Positive HIV antibody.
•12) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema based on chest CT.

发起方

KANEMITSU Yukihide