A phase II study of gemcitabine and nab-paclitaxel followed by chemoradiotherapy with S-1 in patients with locally advanced pancreatic cancer

A phase II study of gemcitabine and nab-paclitaxel followed by chemoradiotherapy with S-1 in patients with locally advanced pancreatic cancer - A phase II study of gemcitabine and nab-paclitaxel followed by chemoradiotherapy with S-1 in patients with locally advanced pancreatic cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026525

Enrollment

Registered

2017-03-13

Start date

2017-03-14

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

GEM+nab-PTX for 12 weeks or 3cycles: nab-PTX 125mg/m2 day1, 8, 15 every 4 weeks GEM 1000 mg/m2 day1, 8, 15 every 4 weeks S-1+RT: S-1 80/100/120 mg/day based on BSA, day1-14 and 22-35 RT 1.8Gy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Radiographic diagnosis of pancreatic ductal adenocarcinoma and histologic or cytologic confirmation of adenocarcinoma (2)Unresectable locally advanced pancreatic cancer without distant metastases (3)No evidence of gastroduodenal invasion or obstruction (4)Age: 20-75 (5)ECOG PS: 0 or 1 (6)No prior chemotherapy or radiotherapy (7)Written informed consent (8)Adequate organ function

Exclusion criteria

Exclusion criteria: (1)Severe concurrent disease (2)Interstitial pneumonia or severe pulmonary emphysema (3)Clinically significant mental disorder (4)Active concomitant malignancy (5)Moderate or severe diarrhea, hemorrhagic colitis or peptic ulcer (6)Infection requiring systemic treatment (7)Fever of 38 degrees centigrade or higher (8)Pregnant or lactating females (9)Under treatment with systemic steroid or immunosuppressive agent (10)Severe drug hypersensitivity (11)Regular use of phenytoin, warfarin or frucitocin (12)Gr2 or more peripheral sensory neuropathy (13)Inappropriate for entry onto the study, as diagnosed by primary physician

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Countries

Japan

Contacts

Public ContactKentaro Sudo

Chiba Cancer Center Gastroenterology

ksudo@chiba-cc.jp043-264-5431

Outcome results

None listed

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