Gemcitabine With or Without Radiation Therapy in Treating Patients With Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Gemcitabine; radiation therapy
Intervention description: Induction: Patients receive the first cycle of gemcitabine 1000 mg/m^2 intravenously once per week for 6 weeks followed by 1 week rest.
Consolidation: Following the week of rest, treatment resume with gemcitabine 1000 mg/m^2 administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles.; Induction: Patients receive gemcitabine 600 mg/m^2 intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose is given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction is 180 cGy prescribed to the isocenter. The total dose of radiation is 5040 cGy given in 28 fractions over 5 1/2 weeks.
Consolidation: Additional cycles of gemcitabine begin approximately 4 weeks after completion of radiation therapy.
Intervention MeSH terms: Gemcitabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage III pancreatic cancer; adenocarcinoma of the pancreas

Summary:

      RATIONALE: Drugs used in chemotherapy work in 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. It is not yet known whether gemcitabine is more effective with or without
      radiation therapy in treating pancreatic cancer.

      PURPOSE: Randomized phase III trial to study the effectiveness of gemcitabine with or without
      radiation therapy in treating patients who have locally advanced, unresectable pancreatic
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed adenocarcinoma of the pancreas

               -  Locally advanced or regional (encompassable within the same radiotherapy portals)

               -  Adenosquamous cancers are allowed

          -  Unresectable disease

          -  Measurable and/or non-measurable disease as determined by computed tomography (CT)
             scan or magnetic resonance imaging (MRI), which must be performed within 4 weeks prior
             to randomization.

          -  Age>=18

          -  ECOG Performance status of 0-1

          -  Life expectancy >= 12 weeks

          -  Adequate bone marrow reserve,liver and renal function within 2 weeks of randomization:

               -  Absolute granulocyte count at least 2,000/mm^3

               -  Platelet count at least 100,000/mm^3

               -  Bilirubin less than 3 mg/dL (unless secondary to biliary obstruction or
                  cholangitis)

               -  Serum glutamic-oxaloacetic (AST) less than 5 times upper limit of normal (ULN)

               -  Albumin greater than 2.5 g/dL

               -  Creatinine no greater than 1.5 times ULN

          -  Fertile patients must use effective contraception

          -  Willing and able to attend follow-up visits

          -  Concurrent enrollment on protocol ECOG-E1Y03 allowed

          -  More than 4 weeks since prior investigational agents

        Exclusion Criteria:

          -  Candidate for surgical excision based on local extent of disease (e.g., T3, N1, M0)

          -  Stage M1 disease

          -  Small cell, mucinous cystadenocarcinoma, islet cell or papillary cystic histology

          -  Pregnant or nursing

          -  Active infection within within 4 weeks of randomization

          -  Malignancy within the past 5 years except nonmelanoma skin cancer, carcinoma in situ
             of the cervix, or organ-confined prostate cancer (Gleason score no greater than 7)

          -  History of active collagen vascular disease (i.e., systemic lupus erythematosus,
             rheumatoid arthritis, or scleroderma)

          -  Signs or symptoms of peptic or duodenal ulcer disease

          -  Concurrent serious systemic disorders that are incompatible with study participation

          -  Prior chemotherapy for pancreatic cancer

          -  Prior radiotherapy

          -  Concurrent intensity modulated radiotherapy