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Prospective Observational Analysis Of CR With Sunitinib Treatment In mRCC Patients

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
CHU Strasbourg
Strasbourg, Cedex, 67091 France
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Complete Remission in Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-99 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients with metastatic renal cell carcinoma, histopathologically confirmed

- Treated with sunitinib according to Smpc

- For cases: Achieving a CR (local assessment according to RECIST V1.0 criteria) with
Sunitinib in prior 6 months alone OR in combination with local treatment (surgery,
radiation therapy, ablative techniques: cryotherapy, RFA)

- For controls: Life expectancy > 3 months No prior Sunitinib treatment

- Patient >18 years

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Sunitinib administered in a non-approved label

- For cases: CR occurring without sunitinib treatment

- For controls: Prior systemic treatment

NCT01934452
Pfizer
Recruiting
Prospective Observational Analysis Of CR With Sunitinib Treatment In mRCC Patients

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Complete Remission in Renal Cell Carcinoma
NCT01934452
All Genders
18+
Years
Multiple Sites
Descriptive Information
Brief TitleProspective Observational Analysis Of CR With Sunitinib Treatment In mRCC Patients
Official TitleProspective Observational Analysis Of CR With Sunitinib Treatment In mRCC Patients
Brief Summary

This prospective study will investigate the characteristics of mRCC patients at time of CR in comparison with mRCC patients non on CR treated with Sunitinib, in order to provide some answers/ refection leads to the following questions :

Can we identify blood specificity at time of CR vs non on CR? Shall we distinguish CR with sunitinib alone from combined CR (sunitinib with local treatment), while in clinical report these 2 cohorts present similar time to recurrence (ALBIGES, ASCO 2010)? Can we identify potential predictive serum biomarkers of recurrence? (With the aim of isolating blood biomarker that can help on treatment discontinuation decision?)

Detailed Description

The main objective of the study is to describe the characteristics of mRCC patients on CR with Sunitinib (Cases) and compare them to the characteristics of mRCC patients non on CR (controls) in order to identify factors associated with the occurrence of complete remission.

The results obtained on the sample must be representative of the population targeted by the study. The most appropriate method to obtain a representative sample is probability sampling.

A sample size of N = 40 (cases) and N = 80 (Controls) will provide a power of 80% in the detection of a frequency difference between cases and controls corresponding to an OR of 0.24 for a parameter frequency 10% in control arm and an OR of 0.30 for a parameter frequency of around 30% in control arm. The significance level was set at bilateral 5%.

The data will be analyzed using SAS software (version 9.1 - SAS Institute, North Carolina, United States).

Study TypeObservational
Study DesignObservational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenRetention:   Samples Without DNA
Description:
whole blood and serum
Sampling MethodProbability Sample
Study Populationcomplete remission in mRCC patients treated with sunitinib versus non complete remission in mRCC patients treated with sunitinib
ConditionComplete Remission in Renal Cell Carcinoma
Intervention
  • Drug: sunitinib
    50 mg 4/2 ,oral, once a day 4 weeks on and 2 weeks off for 6 months
    Other Name: Cases
  • Drug: sunitinib
    50 mg 4/2 ,oral, once a day 4 weeks on and 2 weeks off for 6 months
    Other Name: Controls
Study Groups/Cohorts
  • Complete Remission
    Complete remission arm in mRCC patients treated with sunitinib.
    Intervention: Drug: sunitinib
  • Non Complete Remission
    Non complete remission arm in mRCC patients treated with sunitinib.
    Intervention: Drug: sunitinib
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusRecruiting
Estimated Enrollment
 (submitted: August 29, 2013)
120
Original Estimated EnrollmentSame as current
Estimated Study Completion DateApril 15, 2020
Estimated Primary Completion DateApril 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with metastatic renal cell carcinoma, histopathologically confirmed
  • Treated with sunitinib according to Smpc
  • For cases: Achieving a CR (local assessment according to RECIST V1.0 criteria) with Sunitinib in prior 6 months alone OR in combination with local treatment (surgery, radiation therapy, ablative techniques: cryotherapy, RFA)
  • For controls: Life expectancy > 3 months No prior Sunitinib treatment
  • Patient >18 years

Exclusion Criteria:

  • Sunitinib administered in a non-approved label
  • For cases: CR occurring without sunitinib treatment
  • For controls: Prior systemic treatment
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy VolunteersNo
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location CountriesFrance
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01934452
Other Study ID NumbersNRA6180080
A6181209 ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 2019

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