Intensity-Modulated Radiation Therapy and Gemcitabine in Treating Patients With Locally Advanced Pancreatic Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Pathologically confirmed adenocarcinoma or poorly differentiated carcinoma of the pancreas, ampulla of Vater, or distal bile duct
• •* Locally advanced disease
• •* Medically inoperable, unresectable, or borderline resectable disease
• •* No previously resected disease (i.e., status post-pancreaticoduodenotomy)
• •No non-adenocarcinoma, adenosquamous carcinoma, islet cell carcinoma, cyst adenoma, cystadenocarcinoma, carcinoid tumor, or duodenal carcinoma
• •No lesions in the tail of the pancreas and/or splenic artery/vein involvement/encasement
• •No recurrent or metastatic (M1) disease
• •PATIENT CHARACTERISTICS:
• •Karnofsky performance status 60-100%
• •WBC \> 3,000/μL
• •Platelet count \> 100,000/μL
• •Bilirubin ≤ 2 mg/dL
• •SGOT \< 5 times upper limit of normal (ULN)
• •Creatinine \< 1.5 times ULN
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •Adequate oral nutrition (e.g., ≥ 1,500 calories/day, stable weight for ≥ 2 weeks, and ≤ 5% weight loss)
• •No active malignancy within the past 3 years, except cervical carcinoma in situ or nonmelanoma skin cancer that has been removed
• •No severe, active comorbidity, including any of the following:
• •* Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
• •* Transmural myocardial infarction within the past 6 months
• •* Acute bacterial or fungal infection requiring IV antibiotics at the time of study registration
• •* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within the past month or precluding study therapy at the time of study registration
• •* Active hepatitis, decompensated cirrhosis, or clinically significant liver failure
• •* Other severe comorbid condition, as determined by the principal investigator
• •PRIOR CONCURRENT THERAPY:
• •See Disease Characteristics
• •No prior chemotherapy
• •No prior radiotherapy to any upper abdominal site
• •No concurrent prophylactic colony-stimulating factors during radiotherapy
• •No concurrent warfarin
• •No other concurrent chemotherapy, immunotherapy, hormonal cancer therapy, radiotherapy, surgery for cancer, or experimental therapy