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Preoperative gemcitabine plus nab-paclitaxel, concurrent 3D conformal radiation therapy for borderline resectable pancreatic cancer: Phase I study

Preoperative gemcitabine plus nab-paclitaxel, concurrent 3D conformal radiation therapy for borderline resectable pancreatic cancer: Phase I study - GEM/nabPTX CRT for BR pancreatic cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012456
Enrollment
42
Registered
2013-12-03
Start date
2013-12-03
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

pancreatic cancer

Interventions

Induction chemotherapy with GEM/n-P followed by GEM/n-P CRT.

Sponsors

Department of Gastroenterological Surgery, Osaka Medical Center for Cancer & Cardiovascular Diseases
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Patients with BR pancreatic cancer involving 180 degree of less of the circumference of the SMA, CA, or CHA. (2)Performance Status (ECOG): 0 or 1 (3)Adequate bone marrow reserves, liver/renal functions: WBC: >=3500/mm3, =<;12000/mm3 Neutrophil: >=1500/mm3 Platelet: >=100000/mm3 Hb: >=9.5g/dL AST, ALT, AL-P: less than twofold of the upper limit of normal range T-Bil: =<1.5mg/dL Cr: =<1.2mg/dL CCr: >=50ml/min PaO2: >=70torr (4)Life expectancy more than 6 months (5)Written informed consent

Exclusion criteria

Exclusion criteria: (1)evident infection (2)Lung fibrosis or intestinal pneumonia, and anamnesis or imaging findings. (3)Severe complication(liver cirrhosis, uncontrolled diabetes etc) (4)the onset of myocardial infarction within 3 months (5)active synchronous malignancy (6) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy (7)history of severe drug allergy (8)neuropathy (9)patients who are judged inappropriate for the entry of the trial by the investigators

Design outcomes

Primary

MeasureTime frame
Safety

Countries

Japan

Contacts

Public ContactHidenori Takahashi

Osaka Medical Center for Cancer and Cardiovascular Diseases Gastroenterological Surgery

takahasi-hi@mc.pref.osaka.jp+81-6-6972-1181

Outcome results

None listed

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