Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Central European Cooperative Oncology Group |
---|---|
Information provided by: | Central European Cooperative Oncology Group |
ClinicalTrials.gov Identifier: | NCT00311467 |
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.
Condition | Intervention | Phase |
---|---|---|
Renal Cell Cancer |
Drug: Capecitabine, Interferon, Interleukin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Combined Treatment With Capecitabine and Immunotherapy Versus Immunotherapy Alone in Advanced Renal Cell Carcinoma: a Prospective, Randomized, Multi-Center phaseIII-Trial |
Enrollment: | 172 |
Study Start Date: | March 2004 |
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
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
Ages Eligible for Study: | 19 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Austria | |
Univ. Klinik f. Innere Medizin, Abt. Onkologie | |
Vienna, Austria, 1090 |
Principal Investigator: | Manuela Schmidinger, Prof | Univ. Klinik f. Innere Med. I, Abt. Onkologie |
Study ID Numbers: | CECOG RCC 1.3.001 |
Study First Received: | April 5, 2006 |
Last Updated: | May 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00311467 |
Health Authority: | Austria: Federal Ministry for Health and Women |
renal cell cancer |
Capecitabine Interferons Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Carcinoma |
Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Neoplasms by Histologic Type |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |