Phase I study of oral S-1 plus Gemcitabine and concurrent radiotherapy in patients with locally advanced pancreatic cancer

Phase I study of oral S-1 plus Gemcitabine and concurrent radiotherapy in patients with locally advanced pancreatic cancer - Phase I study of oral S-1 plus Gemcitabine and concurrent radiotherapy in patients with locally advanced pancreatic cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001483

Enrollment

Registered

2008-11-06

Start date

2008-07-01

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

Radiation: 1.8 Gy x 28 fr S1: 60-80mg/sq x 28 days (synchronized with Radiation) GEM: 200-300mg/sq x 6 fr(d1,8,15,22,29,36) Level 0: S1(60mg/sq)+GEM(200mg/sq) Level 1: S1(80mg/sq)+GEM(200mg/sq) L

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)A patient who has been diagnosed pancreatic cancer by diagnostic images and has been proven (or has a schedule for being proven) pancreatic adenocarcinoma histologically. 2)Locally advanced pancreatic cancer; a)UICC stage II with portal or SMV invasion b)UICC stage III 3)No prior operation, chemotherapy or radiotherapy 4)ECOG performance status of 0 or 1 5)Adequate hematologic, cardiac, pulmonary, hepatic and renal function 6)Total bilirubin level is less or equal 3.0mg/dL. 7)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Consciousness disorder 2)NYHA Class of II, III or IV 3)Interstitial pneumonia or pulmonary fibrosis 4)Liver dysfunction of Child-Pugh C 5)Requiring hemodialysis, or serum creatinine level is greater or equal 2.0mg/dL 6)Severe bleeding tendency 7)Poor nutrition (Lymphocyte count is less than 1200, Albumin level is less or equal 2.7g/dL or Pre-albumin level is less or equal 10mg/dL) 8)Acute inflammation 9)Direct invasion of stomach or bowel

Design outcomes

Primary

Measure	Time frame
safety feasibility maximum-tolerated dose recommended dose	—

Secondary

Measure	Time frame
response rate at 4 weeks after accomplishment of whole treatment	—

Countries

Japan

Contacts

Public ContactGoro Honda

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Hepato-Biliary-Pancreatic Surgery

ghon@cick.jp03-3823-2101

Outcome results

None listed

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