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2001-09
2005-12
2010-06
81
NCT00026130
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
INTERVENTIONAL
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2001-11-09 | N/A | 2016-07-15 |
2003-01-26 | N/A | 2016-07-19 |
2003-01-27 | N/A | 2016-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Gemcitabine + 5FU + XRT Chemo and radiation therapy in the treatment of non-metastatic pancreatic cancer | DRUG: fluorouracil
DRUG: gemcitabine hydrochloride
RADIATION: radiation therapy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall Survival | 9 months up to 3 years post treatment |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Time to progression | After 2 cycles of tx, then q 2 mon for 1 yr then q 3 mon for 2 yrs | |
| Clinical Response | q 2 mon for Yr 1 post Tx, then q 3 mon for 2 yrs | |
| CA19-9 Levels | Biomarker response | q cycle, then q 2 mon for 1 yr, then q 3 mon for 2 yrs |
| Toxicity | q cycle |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
