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