Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 12:52 AM
NCT 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
Study:
NCT00311467
Study Brief:
Protocol Section:
NCT00311467