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Spots Global Cancer Trial Database for Combined Treatment With Capecitabine and Immunotherapy Versus Immunotherapy Alone in Advanced Renal Cell Carcinoma

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Trial Identification

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

Study Description

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

Eligibility

Minimum Age: 19 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Univ. Klinik f. Innere Medizin, Abt. Onkologie, Vienna, , Austria

Contact Details

Name: Manuela Schmidinger, Prof

Affiliation: Univ. Klinik f. Innere Med. I, Abt. Onkologie

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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