Fixed Dose Rate Gemcitabine and Cisplatin Followed by Chemoradiation for Locally Advanced Pancreatic Cancer

NCT ID: NCT01396668

Last Updated: 2011-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2011-06-30

Brief Summary

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This is a phase Ⅱ trial of fixed dose rate gemcitabine and cisplatin chemotherapy followed by chemoradiation with capecitabine in patients with locally advanced pancreatic cancer.

Detailed Description

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The main purpose of this study is to evaluate the efficacy and safety of fixed dose rate gemcitabine and cisplatin chemotherapy followed by chemoradiation with capecitabine in patients with locally advanced pancreatic cancer.

Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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gemcitabine, cisplatin, capecitabine

Gemcitabine: 1000mg/㎡ (day 1, 8), cisplatin 60mg/㎡ (day 1) Capecitabine: 650mg/㎡ twice a day, during radiotherapy Gemcitabine: 1000mg/㎡ (day 1, 8)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* unresectable locally advanced pancreatic cancer
* no distant metastasis
* histologically confirmed adenocarcinoma of pancreas
* 18-75 of age
* ECOG performance status 0-2
* normal marrow function :

* WBC at least 3,000/mm3 OR Absolute neutrophil count at least 1,500/mm3
* Platelet count at least 100,000/mm3
* normal liver function :

--Bilirubin no greater than 2.0 mg/dL AST less than 3 times upper limit of normal (ULN)
* normal renal function :

--Creatinine no greater than 1.5 times ULN
* signed informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seoul National University Hospital

Principal Investigators

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Seock-Ah Im, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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H-0412-138-005

Identifier Type: -

Identifier Source: org_study_id

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