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Phase II study of chemoradiotherapy combined with gemcitabine and nab-paclitaxel for unresectable locally advanced pancreatic cancer

Phase II study of chemoradiotherapy combined with gemcitabine and nab-paclitaxel for unresectable locally advanced pancreatic cancer - NUPAT 05

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000028116
Enrollment
25
Registered
2017-08-01
Start date
2017-12-04
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

Unresectable locally advanced pancreatic cancer

Interventions

Gemcitabine (800mg/m2) and nab-paclitaxel (100mg/ m2) are planed to be administered on Day 1, 8, 15, respectively concurrent with radiotherapy to 50.4 Gy in 28 fractions fore the treatment of unresect

Sponsors

Nagoya University Pancreatic Tumor Bord
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who were diagnosed to be pancreatic cancer 2) No distant metastasis 3) Diagnosed unresectable locally advanced pancreatic by rresectability defined by NCCN guideline 4) 20 years of age to 75 years of age 5) ECOG performance status score of 0, 1 6) No prior chemotherapy 7) Primary tumor and adjacent lymph nodes can be treated within 10*10 cm radiation field 8) Enough biliary drainage 9) No invasion to digestive tract 10) No synchronic cancer of other organs 11) Enough oral intake 12) Life expectancy at least 3 months 13) Adequate major organs' function

Exclusion criteria

Exclusion criteria: 1) Distant metastasis 2) Allergy to gemcitabine or nab-paclitaxel 3) Invasion to digestive tract 4) Severe allergy to drags 5) Infection 6) Severe cardiovascular disease 7) Severe basal disease 8) Double cancer 9) Peripheral sensory neuropathy or myelopathy 10) ascites or pleural effusion 11) Active digestive tract bleeding 12) Severe diarrhea 13) Fibroid lung 14) History of radiotherapy for abdomen 15) Uncontrolled cancer pain 16) Lung would be included within radiation field 17) Uncontrolled severe mental disease 18) Pregnant 19) Not obtained consent to this trail 20) Not appropriate for the study at the physician's assessment.

Design outcomes

Primary

MeasureTime frame
2-year survival rates

Countries

Japan

Contacts

Public ContactSuguru Yamada

Nagoya University Graduate School of Medicine Gastroenterological Surgery

suguru@med.nagoya-u.ac.jp(81)52-744-2249

Outcome results

None listed

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