Tivozanib - Real World Experience on Tolerability, Patient Reported Outcomes and QoL in 1st line aRCC
- Conditions
- C64Malignant neoplasm of kidney, except renal pelvis
- Registration Number
- DRKS00018094
- Lead Sponsor
- EUSA Pharma GmbH
- Brief Summary
The T-Rex study confirms the high efficacy and good tolerability of tivozanib in the first-line treatment of advanced renal cell carcinoma. The high efficacy of the treatment was demonstrated by a significant reduction in tumor growth in the participating patients. The therapy was also extremely promising in terms of the response rate, as a high number of patients received partial treatment or even achieved complete remission. In addition to the effectiveness, the good tolerability of the treatment method was also confirmed. Patients reported comparatively few and easily manageable side effects, which helped maintain quality of life during treatment. Tolerability was crucial factor that supported patient adherence and led to continuous and successful treatment. The results of this non-interventional study contribute to a deeper understanding of the treatment of renal cell carcinoma and may help to optimize therapeutic approaches. The promising results could lead to this treatment method being used more broadly in clinical practice to offer patients with renal cell carcinoma an effective and tolerable treatment option.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 32
Written informed consent and any locally-required authorization (EU Data Privacy Directive in the EU).
Age > 18 years at time of study entry
Metastatic or locally advanced RCC not amenable to surgery with curative intention.
intended treatment with tivozanib (decision has been prior and independent of this NIS)
Measurable (according to RECIST 1.1) or non-measurable disease are deemed eligible
Prior surgery or radiotherapy is allowed if completed 4 weeks (for minor surgery and palliative radiotherapy for bone pain: 2 weeks) prior to start of treatment and patient recovered from toxic effects.
under 18 Years, not able to consent
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method incidence of treatment-related AEs and SAEs during treatment and up to 30 days after last dose of tivozanib treatment
- Secondary Outcome Measures
Name Time Method treatment-related therapy discontinuations and hospitalizations, objective response rate, duration of response, TTP, time of tivozanib treatment, time to 2nd line treatment. Safety and efficacy in elderly and frail patients