APERCU: Prospective Observational Analysis Of CR With Sunitinib Treatment In mRCC Patients
Study Details
Study Description
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 | Phase |
|---|---|---|
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
Arms and Interventions
| Arm | 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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- Characteristics of study patients [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
- mRCC patients with CR [Baseline up to 36 months]
To describe if mRCC patients with CR maintain or discontinue Sutent
- Presence (rate) or Absence of blood biomarkers [Baseline up to 36 months]
To identify biomarkers (FGF, IL8, VEGF...) of complete response and relapse/progression if occurs
- Presence (rate) or Absence of blood biomarkers [Baseline up to 36 months]
To compare the biomarkers previously identified between the 2 arms (patients with CR versus patients without CR)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients with metastatic renal cell carcinoma, histopathologically confirmed
-
Treated with sunitinib according to Smpc
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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)
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For controls: Life expectancy > 3 months No prior Sunitinib treatment
-
Patient >18 years
Exclusion Criteria:
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Sunitinib administered in a non-approved label
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For cases: CR occurring without sunitinib treatment
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For controls: Prior systemic treatment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de la Timone | Marseille | Cedex 5 | France | 13335 |
| 2 | CHU Strasbourg | Strasbourg | Cedex | France | 67091 |
| 3 | CHRU HOTEL DIEU - Service Urologie | Angers Cedex | France | 49933 | |
| 4 | C.H.U Morvan | Brest | France | 29000 | |
| 5 | Clinique Victor Hugo | Le Mans | France | 72015 | |
| 6 | Institut Paoli-Calmettes | Marseille Cedex 09 | France | 13273 | |
| 7 | Institut Paoli-Calmettes / Hôpital de jour | Marseille Cedex 9 | France | 13273 Cedex 9 | |
| 8 | Hopital Timone Adultes | Marseille Cedex | France | 13385 | |
| 9 | CRLC Val d'Aurelle | Montpellier cedex 05 | France | 34295 | |
| 10 | Hopital Europeen Georges Pompidou | Paris Cedex 15 | France | 75908 | |
| 11 | Centre Hospitalier Lyon Sud | Pierre Bénite Cedex | France | 69495 | |
| 12 | Clinique Chirurgicale de l'Orangerie, Chiliotherapie | Strasbourg | France | 67010 | |
| 13 | Centre Alexis Vautrin | Vandoeuvre les Nancy | France | 54511 | |
| 14 | Institut Gustave Roussy | Villejuif Cedex | France | 94805 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- NRA6180080
- A6181209