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

JRCT ID: jRCTs041180073

Registered date:11/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Locally advanced pancreatic cancer
• Date of first enrollment: 26/10/2017
• Target sample size: 30
• Study type: Interventional

Intervention(s)

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/day, 28fractions, total 50.4Gy

Outcome(s)

• Primary Outcome: Overall survival
• Secondary Outcome: Progression-free survival, objective response rate, CA19-9 response, patterns of progression, adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Sudo Kentaro
• Secondary ID(s): UMIN000026525