Combination Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT00026130|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 19, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: fluorouracil Drug: gemcitabine hydrochloride Radiation: radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Gemcitabine, 5-Fluorouracil and Radiation Therapy in Locally Advanced Non-Metastatic Pancreatic Adenocarcinoma|
|Study Start Date :||September 2001|
|Primary Completion Date :||December 2005|
|Study Completion Date :||June 2010|
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)
- Overall Survival [ Time Frame: 9 months up to 3 years post treatment ]
- Time to progression [ Time Frame: After 2 cycles of tx, then q 2 mon for 1 yr then q 3 mon for 2 yrs ]
- Clinical Response [ Time Frame: q 2 mon for Yr 1 post Tx, then q 3 mon for 2 yrs ]
- CA19-9 Levels [ Time Frame: q cycle, then q 2 mon for 1 yr, then q 3 mon for 2 yrs ]Biomarker response
- Toxicity [ Time Frame: q cycle ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00026130
Show 77 Study Locations
|Study Chair:||Harvey J. Mamon, MD, PhD||Dana-Farber/Brigham and Women's Cancer Center|