Gemcitabine and Radiation Therapy in Treating Patients With Cancer of the Pancreas
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Gemcitabine may make tumor cells more sensitive to radiation therapy. Combining chemotherapy with radiation therapy after surgery may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with radiation therapy in treating patients who have undergone surgery to remove cancer of the pancreas.
Drug: gemcitabine hydrochloride
Procedure: adjuvant therapy
Radiation: radiation therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Trial Of Adjuvant 2'2'-Difluoro-2'-Deoxycytidine (Gemcitabine) And External Beam Radiation For The Treatment Of Resectable Pancreatic Cancer|
|Actual Study Start Date:||December 2000|
|Study Completion Date:||October 3, 2003|
|Primary Completion Date:||October 3, 2003 (Final data collection date for primary outcome measure)|
- Determine the time to disease progression, local control, and survival of patients with previously resected pancreatic cancer treated with adjuvant gemcitabine and radiotherapy.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30-60 minutes on days 1, 4, 8, 11, 15, 18, 22, 25, 29, and 32 and undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38 in the absence of disease progression or unacceptable toxicity.
Beginning at least 4 weeks after chemoradiotherapy, patients without disease progression and with less than 10% weight loss during study receive additional gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for a total of 2 courses.
Patients are followed every 8 weeks for 6 months and then every 3 months for up to 2 years.
PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 2.2 or 3.4 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00010166
|United States, North Carolina|
|Comprehensive Cancer Center at Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157-1082|
|Study Chair:||Arthur William Blackstock, MD||Wake Forest University Health Sciences|