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Prospective study of chemoradiotherapy with gemcitabine and S-1 for borderline resectable or unresectable pancreatic cancer

Prospective study of chemoradiotherapy with gemcitabine and S-1 for borderline resectable or unresectable pancreatic cancer - Prospective study of chemoradiotherapy with gemcitabine and S-1 for borderline resectable or unresectable pancreatic cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011453
Enrollment
50
Registered
2013-08-11
Start date
2013-06-19
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

chemoradiotherapy with gemcitabine and S-1

Sponsors

Multicenter Clinical Study Group of Osaka
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Histologically, radiologically or serologically diagnosed pancreatic adenocarcinoma (2) Borderline resectable or unresectable pancreatic cancer with measurable lesion (3) No prior treatment for pancreatic cancer (4) Age of 20 and more (5) ECOG performance status of 0 or 1 (6) Adequate hematologic, hepatic, renal and respiratory function (7) Orally feedable (8) Clinically normal electrocardiogram (9) Written informed consent

Exclusion criteria

Exclusion criteria: (1) Resectable pancreatic cancer (2) Presence or past history of Interstitial pneumonia or pulmonary fibrosis or possible (3) Watery diarrhea (4) Active infections (excluding viral hepatitis) (5) Severe cardiac disorder, renal disorder, liver disorder, ulcer with bleeding, intestinal tract paralysis, uncontrollable diabetes mellitus (6) Presence of pleural effusion or ascites requiring drainage (7) Presence of metastasis in central nervous system (8) Active double cancer except carcinoma in situ or intramucosal cancer (synchronous double cancer or asynchronous double cancer with disease-free duration to be within 3 years) (9) Treatment with phenytoin, potassium warfarin or flucytosine (10) Pregnant females or nursing mothers who can not stop lactation. Patients or partners, who don't attempt to doing contraception during the study period. (11) Severe mental disorder (12) Severe drug hypersensitivity (13) As determined by the principal investigator or the sub-investigator the subject is not adequate to participate in the trial

Design outcomes

Primary

MeasureTime frame
1-year overall survival (OS)

Secondary

MeasureTime frame
response rate, overall survival (OS), relapse free survival (RFS), progression free survival (PFS), feasibility, curative resection rate

Countries

Japan

Contacts

Public ContactHidetoshi Eguchi

Osaka University Gastroenterological Surgery

heguchi@gesurg.med.osaka-u.ac.jp06-6879-3251

Outcome results

None listed

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