Randomized Controlled Trial of Gemcitabine Combined With 125I Brachytherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00644618
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : March 27, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Locally Advanced Pancreatic Cancer Drug: gemcitabine Other: 125I brachytherapy PLUS gemcitabine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Gemcitabine Combined With 125I Brachytherapy Versus Gemcitabine Alone in Patients With Locally Advanced Pancreatic Cancer
Study Start Date : January 2003
Actual Primary Completion Date : December 2007
Actual Study Completion Date : January 2008

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Arm Intervention/treatment
Active Comparator: A 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

Experimental: B 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

Primary Outcome Measures :
  1. Survival [ Time Frame: 2 years after the inclusion of the last patient ]

Secondary Outcome Measures :
  1. response rate, clinical benefit response, and safety [ Time Frame: 2 month after the treatment finished ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Responsible Party: President Hu Yu, Union hospital, Huazhong University of Science and Technology Identifier: NCT00644618     History of Changes
Other Study ID Numbers: Union Hospital
First Posted: March 27, 2008    Key Record Dates
Last Update Posted: March 27, 2008
Last Verified: March 2008

Keywords provided by Huazhong University of Science and Technology:
pancreatic cancer
locally advanced

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs