Safety and efficacy test of multimodality treatment combining proton beam therapy, hyperthermia, and gemcitabine-nab-paclitaxel therapy for locally advanced pancreatic cancer

Oda Tatsuya0 个研究点目标入组 30 人开始时间: 2022年6月24日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Histological or cytological diagnosis of pancreatic ductal adenocarcinoma (PDAC)
•2) Radiological diagnosed as BR(borderline resectable) or UR-LA(unresectable locally advanced) according to NCCN guideline
•3) Performance Status (PS) : 0-1 (ECOG criteria)
•4) Patients with normal major organ functions (heart, kidney, liver, bone marrow, lung, brain, etc)
•- Hemoglobin >= 9.0g/dl
•- neutrocyte >= 1,500/mm3
•- platelet >= 75,000/mm3
•- total bilirubin <= 3.0mg/dl
•- AST <= ULN x 5
•- ALT <= ULN x 5
•- eGFR> 40mL/min
•5) 20 <=Age <=80
•6) Patients who are possible to receive proton beam radiation
•7) Acquisition of written informed consent

•1) Patients with distant metastasis including paraaortic lumph node metastasis, peritoneal dissemination
•2) Patients with severe drug induced hypersensitivity syndrome
•3) Patients with other invasive cancer concurrently or less than 5 year disease free survival.
•4) Patients with allergy for contrast materials and difficult to diagnosis of panceatic adenocarcioma
•5) Past treatment history for pancreatic cancer and resistance for any treatments
•6) Patients with dose overlap with previous irradiation or this cannot be ruled out
•7) Patients with comorbidities that are contraindications to radiation therapy (active collagen disease, xeroderma pigmentosum, etc.)
•8) Patients with clear endoscopic exposure of cancer in the mucosa of the gastrointestinal tract
•9) Patients with HCV RNA virus-positive or HBs antigen-positive hepatitis
•10) Patients on dialysis with chronic renal failure or Child Pugh B or higher liver cirrhosis
•11)Patients in pregnancy, may be pregnant, wish to become pregnant, or are breastfeeding
•12)Patients with severe mental disability

发起方

Oda Tatsuya