Attempt to improve the clinical outcome of patients with metastatic renal cell carcinoma. Development of more effective anti-cancer therapy for this group of patients.
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Progression free survival at 12 months
Secondary outcome
Overall remission
Overall survival
Safety
Background summary
At 12 months a percentage of 15% is expected following the use of Soraim of the
study is to investigate the efficacy of the combination of standard therapy
with oral Sorafenib and capecitabine (an oral cytotoxic agent) at 12 months as
measured bij percentage progression free disease patients.
Paitents who are eligible for therapy with Sorafenib will be asked to
particpate.
The burden for the patient is more or less equivalent to that if they receive
standard therapy with Sorafnib alone. There is an additional chance of side
effects related to capecitabine, i.e. decline in WBC and platelets, skin
reaction, and diarrhea.
Endpoint: progression free remission at 12 months as measured according to
standard methods by CT scan.
Study objective
Attempt to improve the clinical outcome of patients with metastatic renal cell
carcinoma. Development of more effective anti-cancer therapy for this group of
patients.
Study design
Phase II study with the combination of two drugs, both used for the treatment
of metastatic renal cell carcinoma.
Intervention
Two drugs: Sorafenib and Capecitabine
Study burden and risks
Similar to that during standard therapy with Sorafenib alone
Albinusdreef 2
2333 ZA Leiden
NL
Albinusdreef 2
2333 ZA Leiden
NL
Listed location countries
Age
Inclusion criteria
Advanced renal cell carcinoma (metastatic RCC)
Exclusion criteria
Other types of malignancies
History of cardiac disease
Serious clinical infections
Symptomatic brain metastases
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-005967-82-NL |
| CCMO | NL20351.058.07 |