Combination Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have locally advanced pancreatic cancer.
Drug: gemcitabine hydrochloride
Radiation: radiation therapy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Gemcitabine, 5-Fluorouracil and Radiation Therapy in Locally Advanced Non-Metastatic Pancreatic Adenocarcinoma|
- Overall Survival [ Time Frame: 9 months up to 3 years post treatment ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: After 2 cycles of tx, then q 2 mon for 1 yr then q 3 mon for 2 yrs ] [ Designated as safety issue: No ]
- Clinical Response [ Time Frame: q 2 mon for Yr 1 post Tx, then q 3 mon for 2 yrs ] [ Designated as safety issue: No ]
- CA19-9 Levels [ Time Frame: q cycle, then q 2 mon for 1 yr, then q 3 mon for 2 yrs ] [ Designated as safety issue: No ]Biomarker response
- Toxicity [ Time Frame: q cycle ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2001|
|Study Completion Date:||June 2010|
|Primary Completion Date:||December 2005 (Final data collection date for primary outcome measure)|
Experimental: Gemcitabine + 5FU + XRT
Chemo and radiation therapy in the treatment of non-metastatic pancreatic cancer
200mg/sq m/d CIVI 5/7 days during radiation therapy (wks 1-6)
Other Name: 5FUDrug: gemcitabine hydrochloride
200mg/sq m IV infusion over 30 min wkly (on d 1, 2, OR 3) during radiation tx (wks 1-6) 1000mg/sq m IV infusion over 30 min wkly for 3 weeks during ea chemotherapy cycleRadiation: radiation therapy
4500cGy total in 25 fractions M-F followed by 540cGy in 3 fractions (Total dose 5040cGy)during radiation tx (wks 1-6)
- Determine the overall survival of patients with locally advanced non-metastatic pancreatic adenocarcinoma treated with gemcitabine, fluorouracil, and radiotherapy.
- Determine the time to progression in patients treated with this regimen.
- Determine the overall clinical response in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes once weekly and fluorouracil IV continuously on days 1-5 weekly for 6 weeks. Patients concurrently undergo radiotherapy 5 days a week for 6 weeks.
Three weeks after the completion of chemoradiotherapy, patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-3. Treatment repeats every 4 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year and then every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study within 24 months.