Randomized Controlled Trial of Gemcitabine Combined With 125I Brachytherapy

Phase 3

Completed

• Conditions: Locally Advanced Pancreatic Cancer
• Interventions: Other: 125I brachytherapy PLUS gemcitabine; Drug: gemcitabine

• Registration Number: NCT00644618
• Lead Sponsor: Huazhong University of Science and Technology

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2007-12
• Study Completion: 2008-01
• Status Verified: 2008-03
• Study First Submitted: 2008-03-24
• Study First Submitted QC: 2008-03-24
• Last Update Submitted: 2008-03-24
• Study First Posted: 2008-03-27
• Last Update Posted: 2008-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
B	125I brachytherapy PLUS gemcitabine	-
A	gemcitabine	-

Primary Outcome Measures

Name	Time	Method
Survival	2 years after the inclusion of the last patient

Secondary Outcome Measures

Name	Time	Method
response rate, clinical benefit response, and safety	2 month after the treatment finished