Duration of Treatment With Tyrosine Kinase Inhibitors in the Treatment of Metastatic Renal Cell Carcinoma

Renal Cell Carcinoma Clinical Trial

— TURCOS  

Official title:

Duration of Treatment With TKIs in the Treatment of Metastatic Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01585974
• Other study ID #: 16263
• Secondary ID: NX1211TR
• Status: Completed
• Phase: N/A
• First received: April 25, 2012
• Last updated: October 18, 2016
• Start date: October 2012
• Est. completion date: November 2015

Study information

• Verified date: October 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health General Directorate of Pharmaceuticals and Pharmacy
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: November 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• To be diagnosed as metastatic renal cell carcinoma

• Previous cytokine therapy

• To sign informed consent form (ICF)

Exclusion Criteria:

• Patients not willing to sign informed consent form or who withdraw their consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Other:
• No intervention
All dosage, frequency and duration for drugs will be under the decision of the treating physician

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of treatment: from start of tyrosine kinase inhibitor treatment to permanent discontinuation of the product		After 2 years	No
Secondary	Incidence of treatment-emergent adverse events (TEAE)		After 2 years	Yes
Secondary	Change of Tumor status		Baseline and 2 years	No

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