Gemcitabine or Combination Chemotherapy Followed by Chemoradiation for Stage IB, II, or III Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin,
      epirubicin hydrochloride, fluorouracil, 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. It is not yet known whether
      gemcitabine hydrochloride is more effective when given alone or together with combination
      chemotherapy and radiation therapy in treating patients with pancreatic cancer.

      PURPOSE: This randomized phase II/III trial is studying gemcitabine hydrochloride to see how
      well it works when given alone or together with combination chemotherapy and radiation
      therapy in treating patients with stage IB, stage II, or stage III pancreatic cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Assess the 1-year progression-free survival of patients with stage IB, II, or III
           adenocarcinoma of the pancreas treated with adjuvant therapy comprising gemcitabine with
           vs without cisplatin, epirubicin hydrochloride, and fluorouracil followed by
           chemoradiotherapy with fluorouracil or capecitabine. (Phase II)

        -  Compare the 2-year overall survival of patients treated with these regimens. (Phase III)

      Secondary

        -  Assess the feasibility and toxicity of these regimens in these patients.

        -  Assess the impact of these regimens on the quality of life of these patients.

        -  Assess the pattern of relapse in patients treated with these regimens.

      OUTLINE: This is a multicenter study. Patients are stratified according to participating
      center and radical surgery. Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive gemcitabine hydrochloride IV over 1 hour on days 1, 8, and 15.
           Treatment repeats every 28 days for 3 courses in the absence of disease progression or
           unacceptable toxicity.

        -  Arm II: Patients receive cisplatin IV over 1 hour and epirubicin hydrochloride IV on day
           1 and gemcitabine hydrochloride IV over 1 hour on days 1 and 8. Patients also receive
           fluorouracil IV continuously beginning on day 1 or oral capecitabine. Treatment repeats
           every 28 days for 3 courses in the absence of disease progression or unacceptable
           toxicity.

      Beginning 2-4 weeks after the completion of chemotherapy, patients in both arms undergo
      radiotherapy 5 days a week for 6 weeks. Patients also receive concurrent fluorouracil IV
      continuously or oral capecitabine during radiotherapy.

      After completion of study treatment, patients are followed up every 3 months.
    

Intervention name(s): capecitabine; cisplatin; epirubicin hydrochloride; fluorouracil; gemcitabine hydrochloride
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Given orally; Given IV; Given IV; Given IV; Given IV
Other intervention name(s): XELODA; Cisplatino-TEVA; Farmarubicina; FLuorouracile-TEVA; Gemzar
Intervention MeSH terms: Gemcitabine; Capecitabine; Fluorouracil; Epirubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IB pancreatic cancer; stage II pancreatic cancer; stage III pancreatic cancer; adenocarcinoma of the pancreas