Pancreatic Cancer Research

Clinical trialPhase 2Completed

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Pancreatic Cancer

A Phase II Study of Gemcitabine, Cisplatin and Radiation Therapy in Patients With Locally Advanced Pancreatic Cancer

Outcome
Finished, no results posted
Phase
Phase 2
Status
Completed
Study type
Interventional
Start
September 2001
Expected end
July 2009
Enrollment
48 participants
Sites
26
Primary outcomes
overall survival
Sponsor
Other
Results posted
No
Last update
14 July 2016

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Brief summary public domain (ClinicalTrials.gov)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have locally advanced pancreatic cancer.

Detailed description public domain (ClinicalTrials.gov)

OBJECTIVES: * Determine the efficacy of gemcitabine, cisplatin, and radiotherapy, in terms of 1-year survival, in patients with locally advanced pancreatic cancer. * Determine the toxicity of this regimen in these patients. * Determine the quality of life of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients undergo radiotherapy once daily five days a week for 5.5 weeks. Patients receive gemcitabine IV over 30 minutes followed by cisplatin IV over 1 hour twice a week for the first 3 weeks of radiotherapy. Beginning 4 weeks after the completion of radiotherapy, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at completion of radiotherapy, at completion of chemotherapy, and 3 months after completion of therapy. Patients are followed every 3 months for 2 years and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 20-47 patients will be accrued for this study within 12-28 months.