Clinical trial · Observational
Study of Patients With Metastatic and/or Advanced Renal Cell Carcinoma, Treated With Sunitinib/Axitinib.
A Real World Retrospective Database Study of Patients Diagnosed With Metastatic and/or Advanced Renal Cell Carcinoma and Treated With Sunitinib and/or Axitinib in a Specialist United Kingdom Oncology Centre
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Research Questions: To understand the clinical outcomes of patients treated with sunitinib in first line and axitinib in second line in a real world setting as therapies for metastatic and/or advanced renal cell carcinoma (mRCC). Primary Objective: 1. What is the progression free survival (PFS) of patients treated in first line with sunitinib, and stratified by Memorial Sloan-Kettering Cancer Center / International Metastatic Renal Cell Carcinoma Database Consortium (MSKCC/IMDC) risk category (favourable, intermediate, poor)? 2. What is the progression free survival (PFS) of patients treated in second line with axitinib, and stratified by MSKCC/IMDC risk category (favourable, intermediate, poor)?
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Renal Cell | — | UNRESOLVED | — |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (1)
- label
- Patients with advanced RCC
- description
- Patients with a diagnosis of kidney cancer (renal cell carcinoma, advanced or metastatic)
- interventionNames
- Drug: Sunitinib
- Drug: Axitinib
Primary outcomes (3)
- measure
- Progression Free Survival (PFS)
- timeFrame
- From start of treatment to PD, death or end of treatment, whichever occurred first, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years)
- description
- PFS was duration measured from the first date of each treatment line to the date of disease progression (PD), end of treatment date or date of death. Participants who were on treatment were censored on 30 June 2018. If a participant stopped due to toxicity, the earliest date from the date of progression or end of treatment date was assigned. PD per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 was defined as at least a 20 percent (%) increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered progression.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria 1. Over the age of 18 years 2. Diagnosis of renal cell carcinoma 3. Treatment with sunitinib and/or axitinib 4. Timeframe: from database inception date (2002) until June 30, 2018. Exclusion criteria Patients meeting any of the following criteria will not be included in the study: 1. Under the age of 18 years 2. Diagnosis other than renal cell carcinoma 3. No treatment with sunitinib and/or axitinib
References
Publications (1)
- DERIVEDWaddell T, Pillai M, Armitage K, Graham DM, Moran M, Dilleen M, Holmes S, Sleszynska-Dopiera E, Hawkins R. Real-world effectiveness of first- and second-line anti-angiogenesis therapy in RCC: analysis of a UK-based population. Future Oncol. 2024;20(33):2547-2558. doi: 10.1080/14796694.2024.2385882. Epub 2024 Oct 9. PMID 39382446