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Phase II trial of neoadjuvant combination chemotherapy with gemcitabine and S-1 for locally advanced pancreatic cancer

Phase II trial of neoadjuvant combination chemotherapy with gemcitabine and S-1 for locally advanced pancreatic cancer - Phase II trial of neoadjuvant chemotherapy with gemcitabine and S-1 for locally advanced pancreatic cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001450
Enrollment
35
Registered
2008-10-21
Start date
2008-12-01
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

locally advanced pancreatic cancer

Interventions

S1: bid d1-15 q3w x 3 courses 60mg/sq PO GEM: d1 and d1, q3w x 3 courses 1000mg/sq DIV

Sponsors

Faculty of Medicine, Kyoto University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Histologically proven pancreatic adenocarcinoma 2)UICC stageIII with one of the criteria below; a)tumor abutment of the SMA involving half of the artery circumference b)encasement of a short segment of HA without tumor extension to the celiac axis 3)No prior chemotherapy or radiotherapy 4)Age above 20 5)ECOG performance status of 0 or 1 6)Adequate hematologic, hepatic and renal function 7)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Watery diarrhea 2)Severe mental disorder 3)Active infection 4)Severe complications, such as ileus, heart failure and renal failure 5)Symptomatic pulmonary fibrosis or interstitial pneumonia 6)History of radiation therapy to the chest 7)Marked pleural or peritoneal effusion 8)Active concomitant malignancy 9)Treatment with phenytoin, potassium warfarin or flucytosine

Design outcomes

Primary

MeasureTime frame
pathologically margin negative status

Secondary

MeasureTime frame
response rate, toxicity, progression free survival, overall survival

Countries

Japan

Outcome results

None listed

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