Randomized Controlled Trial of Gemcitabine Combined With 125I Brachytherapy

March 24, 2008 updated by: Huazhong University of Science and Technology

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: 2 years after the inclusion of the last patient
2 years after the inclusion of the last patient

Secondary Outcome Measures

Outcome Measure
Time Frame
response rate, clinical benefit response, and safety
Time Frame: 2 month after the treatment finished
2 month after the treatment finished

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huazhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

March 24, 2008

First Submitted That Met QC Criteria

March 24, 2008

First Posted (Estimate)

March 27, 2008

Study Record Updates

Last Update Posted (Estimate)

March 27, 2008

Last Update Submitted That Met QC Criteria

March 24, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Union Hospital

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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