A Study of Chemoradiotherapy Using Gem Plus Nab-paclitaxel for Pancreatic Cancer

A Phase I Study of Chemoradiotherapy Using Gemcitabine Plus Nab-paclitaxel for Unresectable Locally Advanced Pancreatic Adenocarcinoma

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02272738

Enrollment

Registered

2014-10-23

Start date

2013-08-31

Completion date

2016-04-30

Last updated

2017-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Brief summary

The purpose of this study is to evaluate the clinical safety and efficacy of Gemcitabine plus nab-Paclitaxel chemoradiotherapy and to determine the Maximal Tolerated Dose (MTD) for unresectable locally advanced pancreatic adenocarcinoma.

Detailed description

Gemcitabine plus nab-Paclitaxel is one of the standard chemotherapy for metastatic pancreatic adenocarcinoma. Gemcitabine plus nab-Paclitaxel realize the favorable anti-tumor effect and tolerable toxicity. Gemcitabine plus nab-Paclitaxel is a promising regimen for concurrent chemoradiotherapy, but the investigators need to know the safety in the case of the concurrent chemoradiotherapy.

Interventions

DRUGGemcitabine

Gemcitabine is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks.

DRUGNab-Paclitaxel

Nab-Paclitaxel is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Histologically or cytologically confirmed advanced pancreatic cancer * Locally advanced pancreatic cancer is defined as the presence of a surgically unresectable tumor(involving the celiac axis or the superior mesenteric artery) * Performance Status:0-1(ECOG) * Patients of age =\>20 and 75\> * White Blood Cell (WBC) \>=3,500/mm3,12,000/mm3, * Neutrophils \>=1,500/mm3, platelets=100,000/mm3, * Hemoglobin \>=9.5 g/dl, * GOT \</=2.0 X Upper Limit Number (ULN), * Glutamate Pyruvate Transaminase (GPT) \</=2.0 X ULN, * Alkaline Phosphatase (ALP) \</=2.0 X ULN, * Total bilirubin \<=1.5mg/dl, * Serum creatinine \<=1.2mg/dl, * Creatinine clearance\>=50 ml/min * arterial O2 pressure (PaO2) \>=70torr or arterial O2 saturation (SpO2) \>=96% * Life expectancy more than 3 months. * Written informed consent.

Exclusion criteria

* Active infection * Lung fibrosis or intestinal pneumonia detectable on chest X-ray and CT * Severe complication (heart disease, cirrhosis, diabetes) * Myocardial infarction within 3 months * Active synchronous or metachronous malignancy * Pregnant or lactation women, or women with known or suspected pregnancy * Symptomatic brain metastasis * History of severe drug allergy * Peripheral neuropathy * Patients who are judged inappropriate for the entry into the study by the investigator

Design outcomes

Primary

Measure	Time frame
Number of patients with Adverse Events	1 years

Secondary

Measure	Time frame
Response Rate	1 years
Overall Survival time	2 years

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026