A phase 3 study of gemcitabine and S-1 compared with gemcitabine monotherapy in patients with unresectable advanced pancreatic cancer.

A phase 3 study of gemcitabine and S-1 compared with gemcitabine monotherapy in patients with unresectable advanced pancreatic cancer. - A phase 3 study of GEM and S-1 compared with GEM for unresectable advanced pancreatic cancer.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002244

Enrollment

100

Registered

2009-07-24

Start date

2007-11-01

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

pancreatic cancer

Interventions

S-1 60mg/m2/day is administered orally twice daily from the evening of day 1 to the morning of day 15 followed by a one week rest. Gemcitabine 1000mg/m2 was administered in a 30-min intravenous infusi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Histopathologically proven advanced pancreatic cancer (2)20 - 79 years of age, (3)ECOG PS 0 or 1 (4)No prior chemotherapy or radiotherapy (5)Oral intake is possible (6)Written informed consent (7)Adequate organ function

Exclusion criteria

Exclusion criteria: (1)severe concurrent disease, (2)interstitial pneumonia, (3)massive abdominal or pleural effision (4)mental disoeder, (5)active concomitant malignancy, (6)severe diarrhea, (7)brain metastasis, (8)severe drug hypersensitibity, (9)pregnant or lactating females, (10)regular use of phenytoin, warfarin or frucitocin, (11)inappropriate for entry onto the study, as diagnosed by primary physician.

Design outcomes

Primary

Measure	Time frame
progression free survival	—

Countries

Japan

Contacts

Public ContactKentaro Sudo

Chiba Cancer Center Gastroenterology

kesudou-gi@umin.ac.jp

Outcome results

None listed

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