Status:

COMPLETED

Randomized Controlled Trial of Gemcitabine Combined With 125I Brachytherapy

Lead Sponsor:

Huazhong University of Science and Technology

Conditions:

Locally Advanced Pancreatic Cancer

Eligibility:

All Genders

18-75 years

Phase:

PHASE3

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 e...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2008

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT00644618

Start Date

January 1 2003

End Date

January 1 2008

Last Update

March 27 2008

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