Safety and efficacy of multimodality treatment for locally advanced PDAC

JRCT ID: jRCTs031220160

Registered date:24/06/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: pancreatic cancer
• Date of first enrollment: 16/09/2022
• Target sample size: 30
• Study type: Interventional

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

Outcome(s)

Primary Outcome

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

• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include 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 <= 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 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

Related Information

• Primary Sponsor: Oda Tatsuya
• Source(s) of Monetary Support: University of Tsukuba Hospital