Randomized Controlled Trial of Gemcitabine Combined With 125I Brachytherapy

Study Overview
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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.

Official Title
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Randomized Controlled Trial of Gemcitabine Combined With 125I Brachytherapy Versus Gemcitabine Alone in Patients With Locally Advanced Pancreatic Cancer

Conditions
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Locally Advanced Pancreatic Cancer

Intervention / Treatment
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* Drug: gemcitabine
* Other: 125I brachytherapy PLUS gemcitabine


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: gemcitabine<br>* a 30-minute intravenous infusions of gemcitabine 1,000 mg/m2 weekly×7, followed by a 1-week pause, and then weekly×3<br>|
| Experimental: B<br> | Other: 125I brachytherapy PLUS gemcitabine<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 2 years after the inclusion of the last patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate, clinical benefit response, and safety |  | 2 month after the treatment finished | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatic cancer, locally advanced