Combined Treatment With Capecitabine and Immunotherapy Versus Immunotherapy Alone in Advanced Renal Cell Carcinoma: a Prospective, Randomized, Multi-center phaseIII-Trial
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.
Group B
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
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary study objective is to investigate whether the addition of capecitabine to interferon-alpha-interleukin-2 based immunotherapy may improve progression free survival when compared to immunotherapy alone.
Manuela Schmidinger, Prof
Principal Investigator
Univ. Klinik f. Innere Med. I, Abt. Onkologie
Austria: Federal Ministry for Health and Women
CECOG RCC 1.3.001
NCT00311467
March 2004
May 2007
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