Last updated: 11/07/2018 06:56:54
Non-PAZ RCC Chart Study in US, EU and Asia-Pacific
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Angiogenesis Inhibitor Therapies for Advanced Renal Cell Carcinoma: Toxicity and Treatment Patterns in Clinical Practice from a Global Medical Chart Review Study
Trial description: The goal of this retrospective medical records chart review study is to assess the real-world treatment patterns, safety, efficacy, and costs of anti-angiogenesis agents in patients with advanced renal cell carcinoma (RCC) over the course of angiogenesis inhibitor treatment. No treatment interventions are given as part of this study. Medical records of patients with RCC who received sorafenib, sunitinib, temsirolimus, or bevacizumab will be reviewed and relevant information abstracted. Data abstracted include prescriptions/administration of angiogenesis inhibitors and other anti-cancer agents, tumor response, diagnoses/identification of key adverse events (e.g., diarrhea, fatigue, hypertension, hypothyroidism, hand-foot syndrome), medical resource utilization, and socio-demographic factors (e.g., race, age, gender, insurance type). Chart reviews will be conducted in the US, Italy, France, Spain, Ireland, UK, Taiwan, Korea and Denmark. The observation period for each patient extends from initiation of a patient’s first angiogenesis inhibitor to the earliest of death, loss to follow-up, or end of the study period. Treatment patterns endpoints include rates of dose changes and interruptions, rates of discontinuations, and switching among agents, and reasons for these treatment modifications. Efficacy endpoints include ORR, PFS and OS. Safety endpoints include the proportion of patients experiencing key adverse events. Costs are modeled based on medical resource utilization.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Treatment patterns
Timeframe: Medical records were retrospectively reviewed at oncology centers in several countries from January 1st 2005
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
1
Primary completion date:
Not applicable
Observational study model:
Other
Time perspective:
Retrospective
Clinical publications:
Castellano Guana D, Duh MS, et al. Safety and Treatment Patterns of Angiogenesis Inhibitors in Patients with Advanced Renal Cell Carcinoma in Spain. Expert Op Drug Safety. 2013;12(4):455-463.
Oh WK, McDermott D, Porta C, et al. Angiogenesis Inhibitor Therapies for Advanced Renal Cell Carcinoma: Toxicity and Treatment Patterns in Clinical Practice from a Global Medical Chart Review . Int J Oncol. 2014;44:5-16.
- received treatment at a participating center in US, Italy, France, Spain, Ireland, UK, Taiwan, Korea and Denmark
- diagnosis of Renal Cell Carcinoma (RCC)
- diagnosis of ...
Inclusion and exclusion criteria
Inclusion criteria:
- received treatment at a participating center in US, Italy, France, Spain, Ireland, UK, Taiwan, Korea and Denmark
- diagnosis of Renal Cell Carcinoma (RCC)
- at least one Rx for anti-angiogenesis treatments sorafenib, sunitinib, temsirolimus, or bevacizumab
- subjects age ...
Exclusion criteria:
- diagnosis of ...
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2012-02-04
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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