Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01711268




Registration number
NCT01711268
Ethics application status
Date submitted
2/08/2012
Date registered
22/10/2012
Date last updated
15/05/2014

Titles & IDs
Public title
Sunitinib Drug Levels and Outcomes in Kidney Cancer
Scientific title
Correlating Renal Cell Cancer Treatment Efficacy With Sunitinib Therapeutic Levels and Outcomes
Secondary ID [1] 0 0
HGWH008
Universal Trial Number (UTN)
Trial acronym
CRESTO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to treatment failure (time on sunitinib treatment)
Assessment method [1] 0 0
This duration extends from the date the patient starts sunitinib until the date sunitinib is abandoned. The group with sunitinib concentration below the population median are expected to have a median Time to Treatment Failure (TTF) of approximately 8 months, compared with 14 months in those with sunitinib concentration above the population median.
Timepoint [1] 0 0
Sunitinib duration (median)
Secondary outcome [1] 0 0
Toxicity
Assessment method [1] 0 0
Pre-specified toxicities (BP, fatigue, diarrhoea, stomatitis, hand-foot syndrome) will be graded every 6 weeks
Timepoint [1] 0 0
Every 6 weeks
Secondary outcome [2] 0 0
Overall survival
Assessment method [2] 0 0
Measured from the date of starting sunitinib treatment to the date of death from any cause
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Progression-free survival
Assessment method [3] 0 0
Progression as determined by the clinician according to RECIST 1.1 definitions
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Time to second line therapy
Assessment method [4] 0 0
Date of starting sunitinib treatment to the date further systemic therapy is started
Timepoint [4] 0 0
2 years

Eligibility
Key inclusion criteria
* Metastatic renal cell cancer treated with single agent sunitinib
* No known primary liver disease and no other severe or uncontrolled concurrent medical conditions
* Signed informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients who are unable to sign informed consent
* Patients unable to give blood
* Patients who are pregnant, nursing or not using an effective contraception method
* Patients who had bone-marrow-transplantation prior to sunitinib treatment

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2014
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Crown Princess Mary Cancer Centre, Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Other
Name
Western Sydney Local Health District
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Howard Gurney, MBBS, FRACP
Address 0 0
Crown Princess Mary Cancer Centre, Westmead
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Howard Gurney, MBBS, FRACP
Address 0 0
Country 0 0
Phone 0 0
+61298455200
Email 0 0
howard.gurney@sydney.edu.au
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01711268