Duration of Treatment With Tyrosine Kinase Inhibitors in the Treatment of Metastatic Renal Cell Carcinoma
TURCOS
Duration of Treatment With TKIs in the Treatment of Metastatic Renal Cell Carcinoma
2 other identifiers
observational
151
1 country
1
Brief Summary
This study is a prospective, non-interventional, non-controlled, multi-center, observational cohort study. The medication is prescribed within the regular practice of the physician. Duration and dosage of treatment is solely at the discretion of the attending physician. The primary objective of this study is to assess duration of treatment in Turkish renal cell carcinoma patients treated with TKIs (Tyrosine Kinase Inhibitors) who could not tolerate prior cytokine treatment within the first month of treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2012
CompletedFirst Posted
Study publicly available on registry
April 26, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedOctober 19, 2016
October 1, 2016
2.7 years
April 25, 2012
October 18, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Duration of treatment: from start of tyrosine kinase inhibitor treatment to permanent discontinuation of the product
After 2 years
Secondary Outcomes (2)
Incidence of treatment-emergent adverse events (TEAE)
After 2 years
Change of Tumor status
Baseline and 2 years
Study Arms (1)
Group 1
Interventions
All dosage, frequency and duration for drugs will be under the decision of the treating physician
Eligibility Criteria
Patients diagnosed as metastatic renal cell carcinoma and could not tolerate previous cytokine therapy within the first month of treatment
You may qualify if:
- To be diagnosed as metastatic renal cell carcinoma
- Previous cytokine therapy
- To sign informed consent form (ICF)
You may not qualify if:
- Patients not willing to sign informed consent form or who withdraw their consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Unknown Facility
Many Locations, Turkey (Türkiye)
Related Publications (1)
Benekli M, Gumus M, Ozkan M, Dane F, Elkiran ET, Cicin I, Sevinc A, Aliustaoglu M, Isikdogan A, Meydan N, Oksuzoglu B, Ozyilkan O, Artac M, Ozdemir F, Kilickap S. Tyrosine kinase inhibitors in the treatment of metastatic renal cell cancer patients with early cytokine intolerance: TURCOS, a Turkish national, prospective observational study. J Oncol Pharm Pract. 2021 Oct;27(7):1623-1630. doi: 10.1177/1078155220963535. Epub 2020 Oct 13.
PMID: 33050804DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2012
First Posted
April 26, 2012
Study Start
October 1, 2012
Primary Completion
June 1, 2015
Study Completion
November 1, 2015
Last Updated
October 19, 2016
Record last verified: 2016-10