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preoperative gemcitabine based chemoradiation therapy for resectable and borderline resectable pancreatic cancer phase1 study

preoperative gemcitabine based chemoradiation therapy for resectable and borderline resectable pancreatic cancer phase1 study - Preoperative chemoradiation therapy for pancreatic cancer

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000020977
Enrollment
10
Registered
2016-04-01
Start date
2016-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

resectable and borderline resectable pancreatic cancer

Interventions

gemcitabine (1000mg/m2) treated on day1,8,15,29,36,43,57,64,71 radiation thrapy
54gly(1.8Gly * 30days)

Sponsors

fukushima medical university
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) histopathologically diagnosed pancreatic cancer 2) performance status: 0-1 (eco grade) 3) pancreatic cancer, diagnosed as resectable by enhanced computed tomography 4) patient who expected to have more than 6 month survival at start of the treatment 5) patient with normal organ function white blood cell:>3500/mm3,<10,000/mm3 neutrophil: >2,000/mm3 lymphocyte: >1,500/mm3 platelet: >100,000/mm3 hemoglobin: >9.0g/dl total bilirubin: <2.0mg/dl ast, alt:>150 u/l serum creatinine:<1.2mg/dl

Exclusion criteria

Exclusion criteria: 1) unresectable pancreatic cancer 1 distant organ metastasis 2 peritoneal dissamination 3 para aortic lymph node metastasis 4 pancreatic cancer with artery invasion, such as abdominal aorta, superior mesenteric artery, ceriac artery, common hepatic artery, or proper hepatic artery. 5 portal vein invasion beyond reconstruction patient with interstitial lung disease or fibroid lung patient with severe diarrhea active viral infection excluding viral hepatitis patient with double cancer a woman of childbearing potential patient with severe psychological disorder patient with severe allergy to any drug

Design outcomes

Primary

MeasureTime frame
occurrence of side effect of preoperative gemcitabine based chemoradiation therapy

Secondary

MeasureTime frame
postoperative complication, 2-year recurrence-free survival, 2-year overall survival, recurrence site

Countries

Japan

Contacts

Public ContactNaoya sato

Fukushima medical university Division of Hepato-Biliary-Pancreatic and Transplant surgery

nawoya2U@gmail.com024-547-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026