Gemcitabine, Capecitabine, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving
      radiation therapy that uses a 3-dimensional image of the tumor to help focus thin beams of
      radiation directly on the tumor, and giving radiation therapy in higher doses over a shorter
      period of time, may kill more tumor cells and have fewer side effects. It is not yet known
      which regimen of chemotherapy given together with radiation therapy is more effective in
      treating pancreatic cancer.

      PURPOSE: This randomized phase II trial is comparing the side effects of two regimens of
      gemcitabine and capecitabine given together with radiation therapy and to see how well they
      work in treating patients with locally advanced pancreatic cancer that cannot be removed by
      surgery.
    

Detailed description: 
      OBJECTIVES:

        -  To evaluate the activity, safety, and feasibility of induction chemotherapy comprising
           gemcitabine and capecitabine followed by two different schedules of chemoradiotherapy
           comprising gemcitabine or capecitabine and radiotherapy in patients with locally
           advanced, nonmetastatic, unresectable pancreatic cancer.

        -  To determine which of the two experimental arms gives the highest generic and
           disease-specific aspects of health-related quality of life (HRQL) following treatment.

        -  To determine how HRQL varies during treatment and follow up in both arms.

      OUTLINE: This is a multicenter study.

      All patients receive a first induction therapy comprising gemcitabine IV on days 1, 8, and 15
      and oral capecitabine twice daily on days 1-21. Treatment repeats every 28 days for 3 courses
      in the absence of disease progression or unacceptable toxicity. Following the first induction
      therapy, patients with a WHO performance status of 0-1 who are responding or have stable
      disease that can be encompassed within a radically treatable radiotherapy volume are
      randomized to 1 of 2 treatment arms.

        -  Arm I:

             -  Second induction therapy (weeks 13-16): Patients receive gemcitabine IV once daily
                on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21.

             -  Chemoradiotherapy (weeks 17-22): Patients receive gemcitabine IV once weekly on day
                1 and undergo conformal radiotherapy 5 days a week for 5.5 weeks.

        -  Arm II:

             -  Second induction therapy (weeks 13-16): Patients receive gemcitabine IV once daily
                on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21.

             -  Chemoradiotherapy (weeks 17-22): Patients receive oral capecitabine twice daily on
                days 1-5 and undergo conformal radiotherapy 5 days a week for 5.5 weeks.

      Patients complete quality-of-life questionnaires QLQ-C30 and PAN26 at baseline and at 17, 23,
      26, 39, and 52 weeks.

      After completion of study treatment, patients are followed every 3 months.
    

Intervention name(s): capecitabine; gemcitabine hydrochloride; quality-of-life assessment; 3-dimensional conformal radiation therapy
Intervention type(s): Drug; Drug; Procedure; Radiation
Intervention MeSH terms: Gemcitabine; Capecitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the pancreas; stage II pancreatic cancer; stage III pancreatic cancer