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

Safety and efficacy of multimodality treatment for locally advanced PDAC (TT-LAP)

Oda Tatsuya

University of Tsukuba Hospital

2-1-1 Amakubo,Tsukuba

tatoda@md.tsukuba.ac.jp

Shimomura Osamu

University of Tsukuba Hospital

2-1-1 Amakubo,Tsukuba

+81-29-853-3221

oshimomura@md.tsukuba.ac.jp

Recruiting

June. 24, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

Both

pancreatic cancer

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

Phase 1 part: DLT rate
Phase 2 part: 2 year survival rate

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

+81-29-853-3914

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