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Randomized Controlled Trial of Gemcitabine Combined With 125I Brachytherapy

NCT ID: NCT00644618

Last Updated: 2008-03-27

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

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2008-01-31

Brief Summary

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For patients with unresectable locally advanced pancreatic cancer, the combined use of external-beam radiation therapy (EBRT) and systemic chemotherapy of 5-FU has been widely recognized as the most effective chemoradiotherapy approach.But most patients succumb to local recurrence and metastasis after treatment, and the prognosis remains poor On the basis of the development and superiority of the interstitial brachytherapy and the radiosensitizing effect of gemcitabine, we performed a clinical study to explore the interaction of improved I-125 brachytherapy and gemcitabine and compare the regimen to the standard gemcitabine treatment specifically in patients with non-metastatic, unresectable pancreatic cancer.

Detailed Description

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Conditions

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Locally Advanced Pancreatic Cancer

Keywords

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pancreatic cancer locally advanced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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A

Group Type ACTIVE_COMPARATOR

gemcitabine

Intervention Type DRUG

a 30-minute intravenous infusions of gemcitabine 1,000 mg/m2 weekly×7, followed by a 1-week pause, and then weekly×3

B

Group Type EXPERIMENTAL

125I brachytherapy PLUS gemcitabine

Intervention Type OTHER

125I brachytherapy PLUS a 30-minute intravenous infusions of gemcitabine 1,000 mg/m2 weekly×7, followed by a 1-week pause, and then weekly×3

Interventions

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gemcitabine

a 30-minute intravenous infusions of gemcitabine 1,000 mg/m2 weekly×7, followed by a 1-week pause, and then weekly×3

Intervention Type DRUG

125I brachytherapy PLUS gemcitabine

125I brachytherapy PLUS a 30-minute intravenous infusions of gemcitabine 1,000 mg/m2 weekly×7, followed by a 1-week pause, and then weekly×3

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Histologically proven
* locally advanced pancreatic adenocarcinoma stage
* No systemic metastases
* Age between 18-75
* Karnofsky-Performance Status equal to, or greater than 70 %
* At least a 2-dimensionally measurable tumor lesion
* Adequate renal and liver function
* Written consent statement
* Patients' compliance and geographical proximity
* Life expectancy equal to or greater than 3 months

Exclusion Criteria

* Serious psychological disease
* Pregnancy and inadequate or not secure contraception or breastfeeding women
* Other previous malignant disease in the past two years
* Serious systemic concomitant diseases, excluding participation in a trial
* Other experimental treatment during or within 6 weeks prior to this trial (including chemotherapeutic medicine or immune-therapies)
* Every other condition or therapy assessed by the physician as an eventual risk for the patient or restricting the aims of the trial
* Distant metastasis
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Union hospital, Huazhong University of Science and Technology

Other Identifiers

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Union Hospital

Identifier Type: -

Identifier Source: org_study_id