Randomized Controlled Trial of Gemcitabine Combined With 125I Brachytherapy

Huazhong University of Science and Technology

Status and phase: Completed; Phase 3

Conditions: Locally Advanced Pancreatic Cancer

Treatments: Drug: gemcitabine; Other: 125I brachytherapy PLUS gemcitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT00644618

Union Hospital

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

A

Active Comparator group

Treatment:

Drug: gemcitabine

B

Experimental group

Treatment:

Other: 125I brachytherapy PLUS gemcitabine