Prospective Observational Analysis Of CR With Sunitinib Treatment In mRCC Patients
NCT ID: NCT01934452
Last Updated: 2023-11-13
Study Results
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View full resultsBasic Information
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COMPLETED
77 participants
OBSERVATIONAL
2015-05-21
2022-01-19
Brief Summary
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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?)
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Detailed Description
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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).
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Complete Remission
Complete remission arm in mRCC patients treated with sunitinib.
sunitinib
50 mg 4/2 ,oral, once a day 4 weeks on and 2 weeks off for 6 months
Non Complete Remission
Non complete remission arm in mRCC patients treated with sunitinib.
sunitinib
50 mg 4/2 ,oral, once a day 4 weeks on and 2 weeks off for 6 months
Interventions
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sunitinib
50 mg 4/2 ,oral, once a day 4 weeks on and 2 weeks off for 6 months
sunitinib
50 mg 4/2 ,oral, once a day 4 weeks on and 2 weeks off for 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* For cases: CR occurring without sunitinib treatment
* For controls: Prior systemic treatment
18 Years
99 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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CHU de la Timone
Marseille, Cedex 5, France
CHU Strasbourg
Strasbourg, Cedex, France
CHRU HOTEL DIEU - Service Urologie
Angers, , France
C.H.U Morvan
Brest, , France
Clinique Victor Hugo
Le Mans, , France
Institut Paoli-Calmettes / Hôpital de jour
Marseille, , France
Institut Paoli-Calmettes
Marseille, , France
Hopital Timone Adultes
Marseille, , France
CRLC Val d'Aurelle
Montpellier, , France
Hopital Europeen Georges Pompidou
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Clinique Chirurgicale de l'Orangerie, Chiliotherapie
Strasbourg, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A6181209
Identifier Type: OTHER
Identifier Source: secondary_id
NRA6180080
Identifier Type: -
Identifier Source: org_study_id
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