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Randomized Controlled Trial of Gemcitabine Combined With 125I Brachytherapy

This study has been completed.
Sponsor:
Information provided by:
Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00644618
First received: March 24, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

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 Intervention Phase
Locally Advanced Pancreatic Cancer
 Drug: gemcitabine
Other: 125I brachytherapy PLUS gemcitabine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:
  • Survival [ Time Frame: 2 years after the inclusion of the last patient ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • response rate, clinical benefit response, and safety [ Time Frame: 2 month after the treatment finished ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: January 2003
Study Completion Date: January 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: President Hu Yu, Union hospital, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT00644618     History of Changes
Other Study ID Numbers: Union Hospital
Study First Received: March 24, 2008
Last Updated: March 24, 2008
Health Authority: China: Food and Drug Administration

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
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 16, 2013