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

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000027758
Enrollment
50
Registered
2017-06-14
Start date
2017-06-01
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

pancreatic cancer

Interventions

Induction chemotherapy with GEM/nPTX followed by GEM/nPTX CRT as a preoperative treatment for 3 months.

Sponsors

Department of Gastroenterological Surgery, Osaka International Cancer Institute
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients with resectable and borderline resecable pancreatic cancer (JPS-T3/4) (2) PS(ECOG):0 or 1 (3) Adequate bone marrow reserves, liver/renal function: WBC:>=3,500/mm3, <=12,000/mm3 Neutrophil: >=1,500/mm3 platelet: >=100,000/mm3 Hb: >=9.5g/dL GOT,GPT,ALP: less than 2.5-fold of the upper limit of normal range TBil: <=1.5mg/dL Cr: <=1.2ng/dL Ccr: >=50ml/min (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
Overall survival

Secondary

MeasureTime frame
Disease free survival, Response (either radiological or pathological), R0 resection rate, safety, pattern of recurrence

Countries

Japan

Contacts

Public ContactHidenori Takahashi

Dept. Surgery, Osaka International Cancer Institute Gastroenterological Surgery

takahasi-hi@mc.pref.osaka.jp0669451181

Outcome results

None listed

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