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. 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
172
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
Univ. Klinik f. Innere Medizin, Abt. Onkologie
Vienna, Austria
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.
The study's secondary objectives are to investigate differences in response rates, safety and survival.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.