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

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: Complete Remission in Renal Cell Carcinoma
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 77

Contacts and Locations

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

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

How is the study designed?

Design Details

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

Number of groups / cohorts

2

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	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	To describe if mRCC patients with CR maintain or discontinue Sutent	Baseline up to 36 months
Presence (rate) or Absence of blood biomarkers	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	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

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

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: complete remission
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Sunitinib
• 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.