Combination Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Interventions
- Registration Number
- NCT00026130
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Gemcitabine + 5FU + XRT radiation therapy Chemo and radiation therapy in the treatment of non-metastatic pancreatic cancer Gemcitabine + 5FU + XRT gemcitabine hydrochloride Chemo and radiation therapy in the treatment of non-metastatic pancreatic cancer Gemcitabine + 5FU + XRT fluorouracil Chemo and radiation therapy in the treatment of non-metastatic pancreatic cancer
- Primary Outcome Measures
Name Time Method Overall Survival 9 months up to 3 years post treatment
- Secondary Outcome Measures
Name Time Method Clinical Response q 2 mon for Yr 1 post Tx, then q 3 mon for 2 yrs CA19-9 Levels q cycle, then q 2 mon for 1 yr, then q 3 mon for 2 yrs Biomarker response
Toxicity q cycle Time to progression After 2 cycles of tx, then q 2 mon for 1 yr then q 3 mon for 2 yrs
Trial Locations
- Locations (77)
Northeast Alabama Regional Medical Center
🇺🇸Anniston, Alabama, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Naval Medical Center - San Diego
🇺🇸San Diego, California, United States
Veterans Affairs Medical Center - San Diego
🇺🇸San Diego, California, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Lombardi Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Scroll for more (67 remaining)Northeast Alabama Regional Medical Center🇺🇸Anniston, Alabama, United States