Randomized Controlled Trial of Gemcitabine Combined With 125I Brachytherapy

Locally Advanced Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00644618
• Other study ID #: Union Hospital
• Status: Completed
• Phase: Phase 3
• First received: March 24, 2008
• Last updated: March 24, 2008
• Start date: January 2003
• Est. completion date: January 2008

Study information

• Verified date: March 2008
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Locally Advanced Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival		2 years after the inclusion of the last patient	Yes
Secondary	response rate, clinical benefit response, and safety		2 month after the treatment finished	Yes