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Randomized Controlled Trial of Gemcitabine Combined With 125I Brachytherapy

NCT00644618 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2008-03-27

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

gemcitabine

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

OTHER

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

Sponsors & Collaborators

  • Huazhong University of Science and Technology

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2007-12-31
Completion
2008-01-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00644618 on ClinicalTrials.gov