Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 11:07 PM
Study NCT ID:
NCT00311467
Status:
TERMINATED
Last Update Posted:
2012-05-16
First Post:
2006-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combined Treatment With Capecitabine and Immunotherapy Versus Immunotherapy Alone in Advanced Renal Cell Carcinoma
Sponsor:
Central European Cooperative Oncology Group
Organization:
Study Overview
Official Title:
Combined Treatment With Capecitabine and Immunotherapy Versus Immunotherapy Alone in Advanced Renal Cell Carcinoma: a Prospective, Randomized, Multi-center phaseIII-Trial
Status:
TERMINATED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no patient recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: