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Brief Title: Combined Treatment With Capecitabine and Immunotherapy Versus Immunotherapy Alone in Advanced Renal Cell Carcinoma
Official Title: Combined Treatment With Capecitabine and Immunotherapy Versus Immunotherapy Alone in Advanced Renal Cell Carcinoma: a Prospective, Randomized, Multi-center phaseIII-Trial
Study ID: NCT00311467
Brief Summary: 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.
Detailed Description: 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
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Univ. Klinik f. Innere Medizin, Abt. Onkologie, Vienna, , Austria
Name: Manuela Schmidinger, Prof
Affiliation: Univ. Klinik f. Innere Med. I, Abt. Onkologie
Role: PRINCIPAL_INVESTIGATOR