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

February 14, 2022 updated by: Pfizer

Prospective Study of Complete Remissions Observed With Sunitinib in Patients With Metastatic Renal Cell Carcinoma mRCC)

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?)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

77

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

complete remission in mRCC patients treated with sunitinib versus non complete remission in mRCC patients treated with sunitinib

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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 Names:
  • Controls
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 Names:
  • Controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mRCC patients with CR
Time Frame: Baseline up to 36 months
To describe if mRCC patients with CR maintain or discontinue Sutent
Baseline up to 36 months
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
Baseline up to 36 months
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)
Baseline up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2015

Primary Completion (Actual)

January 19, 2022

Study Completion (Actual)

January 19, 2022

Study Registration Dates

First Submitted

August 2, 2013

First Submitted That Met QC Criteria

August 29, 2013

First Posted (Estimate)

September 4, 2013

Study Record Updates

Last Update Posted (Actual)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 14, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRA6180080
  • A6181209 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Complete Remission in Renal Cell Carcinoma

Clinical Trials on sunitinib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe