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Prospective Observational Analysis Of CR With Sunitinib Treatment In mRCC Patients (APERCU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01934452
Recruitment Status : Completed
First Posted : September 4, 2013
Last Update Posted : February 16, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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?)


Condition or disease Intervention/treatment
Complete Remission in Renal Cell Carcinoma Drug: sunitinib

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 Design
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Study Type : Observational
Actual Enrollment : 77 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Prospective Study of Complete Remissions Observed With Sunitinib in Patients With Metastatic Renal Cell Carcinoma mRCC)
Actual Study Start Date : May 21, 2015
Actual Primary Completion Date : January 19, 2022
Actual Study Completion Date : January 19, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Complete Remission
Complete remission arm in mRCC patients treated with sunitinib.
 Drug: sunitinib
50 mg 4/2 ,oral, once a day 4 weeks on and 2 weeks off for 6 months
Other Name: Cases
Non Complete Remission
Non complete remission arm in mRCC patients treated with sunitinib.
 Drug: sunitinib
50 mg 4/2 ,oral, once a day 4 weeks on and 2 weeks off for 6 months
Other Name: Controls


Outcome Measures
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Primary Outcome Measures :
  1. Characteristics of study patients [ Time Frame: Baseline up to 36 months ]
    To compare characteristics of mRCC patients with CR versus mRCC patients without CR with Sutent, in order to identify factors associated with remission


Secondary Outcome Measures :
  1. mRCC patients with CR [ Time Frame: Baseline up to 36 months ]
    To describe if mRCC patients with CR maintain or discontinue Sutent

  2. Presence (rate) or Absence of blood biomarkers [ Time Frame: Baseline up to 36 months ]
    To identify biomarkers (FGF, IL8, VEGF...) of complete response and relapse/progression if occurs

  3. Presence (rate) or Absence of blood biomarkers [ Time Frame: Baseline up to 36 months ]
    To compare the biomarkers previously identified between the 2 arms (patients with CR versus patients without CR)


Biospecimen Retention:   Samples Without DNA
whole blood and serum

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
complete remission in mRCC patients treated with sunitinib versus non complete remission in mRCC patients treated with sunitinib
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01934452


Locations
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France
CHU de la Timone
Marseille, Cedex 5, France, 13335
CHU Strasbourg
Strasbourg, Cedex, France, 67091
CHRU HOTEL DIEU - Service Urologie
Angers Cedex, France, 49933
C.H.U Morvan
Brest, France, 29000
Clinique Victor Hugo
Le Mans, France, 72015
Institut Paoli-Calmettes
Marseille Cedex 09, France, 13273
Institut Paoli-Calmettes / Hôpital de jour
Marseille Cedex 9, France, 13273 Cedex 9
Hopital Timone Adultes
Marseille Cedex, France, 13385
CRLC Val d'Aurelle
Montpellier cedex 05, France, 34295
Hopital Europeen Georges Pompidou
Paris Cedex 15, France, 75908
Centre Hospitalier Lyon Sud
Pierre Bénite Cedex, France, 69495
Clinique Chirurgicale de l'Orangerie, Chiliotherapie
Strasbourg, France, 67010
Centre Alexis Vautrin
Vandoeuvre les Nancy, France, 54511
Institut Gustave Roussy
Villejuif Cedex, France, 94805
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01934452    
Other Study ID Numbers: NRA6180080
A6181209 ( Other Identifier: Alias Study Number )
First Posted: September 4, 2013    Key Record Dates
Last Update Posted: February 16, 2022
Last Verified: February 2022
Individual Participant Data (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/data_requests.
Keywords provided by Pfizer:
complete remission
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
 Kidney Diseases
Urologic Diseases
Male Urogenital Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action