NIPH Clinical Trials Search

JRCT ID: jRCTs031220160

Registered date:24/06/2022

Safety and efficacy of multimodality treatment for locally advanced PDAC

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedpancreatic cancer
Date of first enrollment16/09/2022
Target sample size30
Countries of recruitment
Study typeInterventional
Intervention(s)Chemotherapy: GEM 800 mg/m2 [Day 1,8,15] nab-paclitaxel 100 mg/m2 [Day 1,8,15] every 4 weeks Proton beam therapy: total 67.5Gy 2.7Gy/fr total: 25fr Hyperthermia: 1h after chemothrapy


Primary OutcomePhase 1 part: DLT rate Phase 2 part: 2 year survival rate
Secondary Outcomeadverse event incident rate, treatment completion rate, response rate, progression free survival, overall survival, resection rate, pathological response rate, R0 resction rate, detection and analysis of circulating tumor cells (CTCs), radiation dose volume evaluation, molecular pathological findings of preoperative biopsy specimen and progonosis analysis, pathological analysis in resected patients after triple-modal treatment

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 80age old
Include criteria1) 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
Exclude criteria1) 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

Related Information


Public contact
Name Osamu Shimomura
Address 2-1-1 Amakubo,Tsukuba Ibaraki Japan 305-8576
Telephone +81-29-853-3221
Affiliation University of Tsukuba Hospital
Scientific contact
Name Tatsuya Oda
Address 2-1-1 Amakubo,Tsukuba Ibaraki Japan 305-8576
Telephone +81-29-853-3221
Affiliation University of Tsukuba Hospital