Phase I/II study of preoperative chemoradiotherapy with Gemcitabine and S-1 for resectable pancreatic cancer

Phase I/II study of preoperative chemoradiotherapy with Gemcitabine and S-1 for resectable pancreatic cancer - Phase I/II study of preoperative chemoradiotherapy with Gemcitabine and S-1 for resectable pancreatic cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002649

Enrollment

Registered

2009-10-19

Start date

2009-10-01

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

resectable pancreatic cancer

Interventions

preoperative chemoradiotherapy with Gemcitabine and S-1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Histologically proven pancreatic adenocarcinoma (2) Age between 20 and 80 years (3) ECOG performance status of 0 or 1 (4) Surgically resectable (5) Life Expectancy must be >=6 months (6) Adequate hematologic, hepatic, renal and respiratory function (7) Interval of at least 4 weeks between prior treatment and start of present study (8) Written informed consent

Exclusion criteria

Exclusion criteria: (1) Unresectable 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

Measure	Time frame
Phase 1: Dose limiting toxicity, maximum tolerated dose, recommended dose Phase 2: Pathological effect	—

Secondary

Measure	Time frame
Response rate, Safety, Curative resection rate, Feasibility, Local recurrence rate, Relapse free survival (RFS), Overall survival (OS)	—

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