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Triacetyluridine and Fluorouracil Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced, or Metastatic Pancreatic Cancer
This study is currently recruiting patients.
Sponsored by: | Wellstat Therapeutics |
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Information provided by: | National Cancer Institute (NCI) |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells. Chemoprotective drugs such as triacetyluridine may protect normal cells from the side effects of chemotherapy. It is not yet known which chemotherapy regimen is more effective in treating pancreatic cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil plus triacetyluridine with that of gemcitabine in treating patients who have locally advanced or metastatic pancreatic cancer that cannot be treated with surgery.
Condition | Treatment or Intervention | Phase |
---|---|---|
adenocarcinoma of the pancreas Drug Toxicity Pancreatic Cancer |
Drug: fluorouracil Drug: gemcitabine Drug: triacetyluridine Procedure: chemoprotection Procedure: chemotherapy Procedure: drug modulation Procedure: high-dose chemotherapy Procedure: supportive care/therapy |
Phase III |
MedlinePlus related topics: Pancreatic Cancer; Poisoning
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Triacetyluridine and High-Dose Fluorouracil Versus Gemcitabine in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to disease stage (II or III vs IV). Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 260 patients (130 per treatment arm) will be accrued for this study within 30 months.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Gastrointestinal:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Location and Contact Information
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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