pancreatic cancer
Conditions
Interventions
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
Sponsors
Oda Tatsuya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 40mL/min 5) 20 <=Age <=80 6) Patients who are possible to receive proton beam radiation 7) Acquisition of written informed consent
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1 part: DLT rate Phase 2 part: 2 year survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse 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 | — |
Contacts
Public ContactOsamu Shimomura
University of Tsukuba Hospital
Outcome results
None listed