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


Phase 3
18 Years
75 Years
Not Enrolling
Both
Locally Advanced Pancreatic Cancer

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Trial Information

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


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

Type of Study:

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

Outcome Measure:

Survival

Outcome Time Frame:

2 years after the inclusion of the last patient

Safety Issue:

Yes

Authority:

China: Food and Drug Administration

Study ID:

Union Hospital

NCT ID:

NCT00644618

Start Date:

January 2003

Completion Date:

January 2008

Related Keywords:

  • Locally Advanced Pancreatic Cancer
  • pancreatic cancer
  • locally advanced
  • Pancreatic Neoplasms

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