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Multi-center, prospective randomised phase III study evaluating capecitabine in combination with standard-immunotherapy versus standard-immunotherapy alone as first-line therapy in patients with metastatic renal cell carcinoma.
Treatment plan Group A
Patients randomised to group A will receive treatment according to the following treatment schedule:
Group A: Combined Chemo-Immunotherapy Chemotherapy: Mo-Fr Immunotherapy
- Week 1:Capecitabine / Interferon;
- Week 2:Capecitabine / Interferon;
- Week 3:REST PERIOD / Interleukin;
- Week 4:Capecitabine / Interleukin;
- Week 5:Capecitabine / REST PERIOD;
- Week 6:REST PERIOD / Interferon;
- Week 7:Capecitabine / Interferon;
- Week 8:Capecitabine / Interleukin;
- Week 9:REST PERIOD / Interleukin;
- Week 10:Capecitabine / REST PERIOD;
- Week 11:Capecitabine / Interferon;
- Week 12:REST PERIOD / Interferon;
- Week 13:Capecitabine / Interleukin;
- Week 14:Capecitabine / Interleukin;
DOSAGES AND ROUTES OF ADMINISTRATION:
Capecitabine orally from day 1 to 14 at a dose of 1000 mg/m2 twice daily every 21 days.
Interferon-alpha subcutaneously on days 1 + 3 + 5 weeks 1 + 2 +6 + 7,11+12 at a dose of 6 MIU/d.
Interleukin-2 subcutaneously on days 1 to 4 in weeks 3 + 4 +8 + 9,13+14 at a dose of 4.5 MIU/day.
Patients randomized to group B will receive treatment according to the same treatment schedule and at the same dosages without capecitabine.
Efficacy evaluations will be performed every 14 weeks of treatment in both groups
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Renal Cell Cancer
Capecitabine, Interferon, Interleukin
Univ. Klinik f. Innere Medizin, Abt. Onkologie
Central European Cooperative Oncology Group
Published on BioPortfolio: 2014-08-27T03:45:21-0400
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