Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      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 before surgery may shrink the tumor so that it
      can be removed during surgery.

      PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens
      combining chemotherapy with radiation therapy in treating patients who are undergoing surgery
      for locally advanced pancreatic cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the percentage of margin-free resections in patients with locally advanced,
           potentially resectable adenocarcinoma of the pancreas treated with gemcitabine and
           radiotherapy vs gemcitabine, fluorouracil, and cisplatin followed by radiotherapy and
           fluorouracil.

        -  Compare the efficacy of these regimens, as measured by CT scan response, in these
           patients.

        -  Compare the posttreatment fibrosis in resected specimens of patients treated with these
           regimens.

        -  Compare the toxicity of these regimens in these patients.

        -  Compare the duration of objective response in patients treated with these regimens.

        -  Compare the disease-free and overall survival of patients treated with these regimens.

        -  Compare the effect of these regimens and disease recurrence on CA 19-9 values in these
           patients.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      superior mesenteric vein (SMV)/portal vein (PV) occlusion (yes vs no), SMV/PV/superior
      mesenteric artery/hepatic artery abutment or narrowing (yes vs no), prior exploration (yes vs
      no), and whether deemed to require preoperative therapy due to other factors (yes vs no).
      Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients undergo radiotherapy once daily 5 days a week for 6 weeks. Patients
           receive gemcitabine IV over 50 minutes once weekly for 6 weeks during radiotherapy.
           Patients undergo surgical resection 4-6 weeks after completion of chemoradiotherapy.

      Maintenance therapy (4-8 weeks after completion of surgery): Patients receive gemcitabine IV
      over 100 minutes once weekly for 2 weeks. Treatment repeats every 3 weeks for 5 courses in
      the absence of disease progression or unacceptable toxicity.

        -  Arm II: Patients receive gemcitabine IV over 30 minutes on days 1, 5, 29, and 33;
           cisplatin IV over 60 minutes on days 1-5 and 29-33; and fluorouracil IV continuously on
           days 1-4 and 29-32. Patients also receive filgrastim (G-CSF) subcutaneously (SC) daily
           on days 6-15 and 34-43 and epoetin alfa SC weekly on weeks 1-9. After completion of
           chemotherapy, patients undergo radiotherapy once daily 5 days a week for 6 weeks.
           Patients receive fluorouracil IV continuously daily during radiotherapy. Patients
           undergo surgical resection 4-6 weeks after completion of chemoradiotherapy.

      Maintenance therapy (4-8 weeks after completion of surgery): Patients receive gemcitabine IV
      over 100 minutes once weekly for 2 weeks. Treatment repeats every 3 weeks for 3 courses in
      the absence of disease progression or unacceptable toxicity.

      Patients are followed every 3 months for 2 years and then every 6 months for 2 years.

      PROJECTED ACCRUAL: A total of 80-160 patients (40-80 per treatment arm) will be accrued for
      this study.
    

Intervention name(s): epoetin alfa; filgrastim; cisplatin; fluorouracil; gemcitabine hydrochloride; adjuvant therapy; conventional surgery; neoadjuvant therapy; radiation therapy
Intervention type(s): Biological; Biological; Drug; Drug; Drug; Procedure; Procedure; Procedure; Radiation
Intervention MeSH terms: Gemcitabine; Fluorouracil; Epoetin Alfa
Allocation: Randomized
Primary purpose: Treatment
Keywords: adenocarcinoma of the pancreas; stage II pancreatic cancer; stage III pancreatic cancer