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Phase I study of chemoradiotherapy using gemcitabine plus nab-paclitaxel for unresectable locally advanced pancreatic cancer

Phase I study of chemoradiotherapy using gemcitabine plus nab-paclitaxel for unresectable locally advanced pancreatic cancer - Phase I study of chemoradiotherapy using gemcitabine plus nab-paclitaxel for unresectable locally advanced pancreatic cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000020475
Enrollment
24
Registered
2016-01-07
Start date
2016-03-01
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

unresectable locally advanced pancreatic cancer

Interventions

(1)Concurrent radiotherapy is delivered in 28 fractions (a total dose of 50.4Gy). (2)Gemcitabine+Nab-Paclitaxel is intravenously administered on day 1,8 and 15 every 4 weeks.

Sponsors

Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)pancreatic cancer (2)no distant metastasis (3)unresectable defined by NCCN guideline (4)age 20-75 (5)Performance Status:0-1(ECOG) (6)initial treatment (7)Radiotherapist determines that all of the primary tumor and lymph node metastasis is possible to be included in the radiation field of 10cm X 10cm (8)biliary drainage for obstructive jaundice (9)no invasion of digestive tract (10)no other organ cancer (11)adequate oral intake (12)Life expectancy more than 3 months (13)adequate organ function (bone marrow, liver, kidney etc) (14)written informed consent

Exclusion criteria

Exclusion criteria: (1)other distant metastasis (2)allergy of gemcitabine or nab-paclitaxel (3)invasion of digestive tract (4)severe drug allergy (5)active infection (6)severe heart disease (7)severe complications(bowel obstruction, lung fibrosis, interstitial pneumonia, diabetes, renal failure, liver cirrhosis) (8)active synchronous cancer (9)peripheral neuropathy (10)uncontrollable ascites or pleural effusion (11)active gastrointestinal bleeding (12)severe diarrhea (13)mental disorder (14)pregnancy (15)no informed consent (16)inappropriate case (17)pulmonary fibrosis, interstitial pneumonia (18)history of abdominal irradiation (19)uncontrollable carcinomatous pain (20)Lung in the pulmonary field

Design outcomes

Primary

MeasureTime frame
incidence of dose limiting toxicity (within 2 courses)

Countries

Japan

Contacts

Public ContactTsutomu Fujii

Nagoya University Graduate School of Medicine Department of Gastroenterological Surgery (Surgery II)

fjt@med.nagoya-u.ac.jp052-744-2245

Outcome results

None listed

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