Clinical trial NCT01934452: Prospective Observational Analysis Of CR With Sunitinib Treatment In mRCC Patients
Official title: Prospective Study of Complete Remissions Observed With Sunitinib in Patients With Metastatic Renal Cell Carcinoma mRCC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complete Remission in Renal Cell Carcinoma
Keywords: complete remission
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-09-04
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: complete remission in mRCC patients treated with sunitinib versus non complete remission in mRCC patients treated with sunitinib

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?)

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).

Eligibility 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

Primary outcomes:
measure: Time to Diagnose Metastatic Renal Cell Carcinoma
timeFrame: Baseline (at inclusion Visit)
measure: Number of Participants Categorized According to Presence of Nephrectomy
timeFrame: Baseline (at inclusion Visit)
measure: Number of Participants Categorized According to Type of Nephrectomy
timeFrame: Baseline (at inclusion Visit)
measure: Time to Nephrectomy From Diagnosis of Metastatic Renal Cell Carcinoma (mRCC)
timeFrame: Baseline (at inclusion Visit)
measure: Number of Participants Categorized According to Pathological Classification
timeFrame: Baseline (at inclusion Visit)
measure: Number of Participants Categorized According to Tumor, Node, Metastasis (TNM) Classification
timeFrame: Baseline (at inclusion Visit)
measure: Tumour Size
timeFrame: Baseline (at Inclusion Visit)
measure: Number of Participants Categorized According to Fuhrman Nuclear Grade
timeFrame: Baseline (at Inclusion Visit)
measure: Number of Participants Categorized According to Presence of Necrosis, Pulmonary Embolism and Sarcomatoid Component
timeFrame: Baseline (at Inclusion Visit)
measure: Time to Initiation of Sunitinib From Diagnosis of Metastatic Renal Cell Carcinoma (mRCC)
timeFrame: Diagnosis of mRCC to Sunitinib Initiation (at Inclusion Visit)
measure: Number of Participants Categorized According to Location of Metastases
timeFrame: At initiation of sunitinib (at Inclusion Visit)
measure: Number of Participants Categorized According to Type of Lymph Nodes as Metastatic Site
timeFrame: At initiation of sunitinib (at Initiation Visit)
measure: Number of Participants Categorized According to Recurrence at Nephrectomy Site
timeFrame: At initiation of sunitinib (at Inclusion Visit)
measure: Number of Participants Categorized According to Recurrence at Other Site
timeFrame: At initiation of sunitinib (at Inclusion Visit)
measure: Number of Metastatic Sites
timeFrame: At initiation of sunitinib (at Initiation Visit)
measure: Number of Participants Categorized According to Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Classification
timeFrame: At initiation of sunitinib (at Inclusion Visit)
measure: Time to Achieve Complete Remission (CR) After Sunitinib Initiation: mRCC Participants With CR
timeFrame: From initiation of sunitinib till CR (data collected at Inclusion Visit)
measure: Number of Participants Categorized According to Method of Achieving CR: mRCC Participants With CR
timeFrame: From initiation of sunitinib till CR (data collected at Inclusion Visit)
measure: Number of Participants Categorized According to Type of Medical Treatment Alone: mRCC Participants With CR
timeFrame: From initiation of sunitinib till CR (data collected at Inclusion Visit)
measure: Number of Participants Categorized According to Treatment Combined With Local Treatment: mRCC Participants With CR
timeFrame: From initiation of sunitinib till CR (data collected at Inclusion Visit)
measure: Number of Participants Categorized According to Radiological Assessment of the CR: mRCC Participants With CR
timeFrame: From initiation of sunitinib till CR (data collected at Inclusion Visit)
measure: Number of Participants Categorized According to Therapeutic Strategy After CR: mRCC Participants With CR
timeFrame: After achieving CR with sunitinib treatment (data collected at Inclusion Visit)
measure: Number of Participants With Disease Evolution (DE) at Month 12 Follow-up Visit: mRCC Participants With CR
timeFrame: Month 12 follow-up visit
measure: Number of Participants With Ongoing Sunitinib Treatment at Month 12 Follow-up Visit: mRCC Participants With CR
timeFrame: Month 12 follow-up study visit
measure: Number of Participants With Ongoing Sunitinib Treatment According to Dose and Regimen at Month 12 Follow-up Visit: mRCC Participants With CR
timeFrame: Month 12 follow-up study visit
measure: Number of Participants Who Discontinued Sunitinib Temporarily at Month 12 Follow-up Visit: mRCC Participants With CR
timeFrame: Month 12 follow-up study visit
measure: Number of Participants Categorized According to Number of Temporary Discontinuations of Sunitinib Treatment at Month 12 Follow-up Visit: mRCC Participants With CR
timeFrame: Month 12 follow-up study visit
measure: Number of Instances When Different Types of Reason Led to Temporary Discontinuation of Sunitinib Treatment at Month 12 Follow up Visit: mRCC Participants With CR
timeFrame: Month 12 follow-up study visit
measure: Number of Instances When Participants Resumed Sunitinib Treatment After Temporary Discontinuation at Month 12: mRCC Participants With CR
timeFrame: Month 12 follow-up study visit
measure: Duration of Temporary Discontinuation of Sunitinib Treatment at Month 12 Follow-up Visit: mRCC Participants With CR
timeFrame: Month 12 follow-up study visit
measure: Number of Participants Who Discontinued Sunitinib Permanently at Month 12 Follow-up Visit: mRCC Participants With CR
timeFrame: Month 12 follow-up study visit
measure: Number of Participants Categorized According to Reasons for Permanent Discontinuations of Sunitinib Treatment at Month 12 Follow-up Visit: mRCC Participants With CR
timeFrame: Month 12 follow-up visit
measure: Duration of Treatment With Sunitinib Since Complete Remission at Month 12 Follow-up Visit: mRCC Participants With CR
timeFrame: Month 12 follow-up study visit
measure: Number of Participants With Disease Evolution at Month 24 Follow-up Visit: mRCC Participants With CR
timeFrame: Month 24 follow-up study visit
measure: Number of Participants With Ongoing Sunitinib Treatment at Month 24 Follow-up Visit: mRCC Participants With CR
timeFrame: Month 24 follow-up study visit
measure: Number of Participants Who Discontinued Sunitinib Temporarily at Month 24 Follow-up Visit: mRCC Participants With CR
timeFrame: Month 24 follow-up study visit
measure: Number of Participants Who Resumed Treatment at Month 24 Follow-up Visit: mRCC Participants With CR
timeFrame: Month 24 follow-up study visit
measure: Number of Days of Temporary Discontinuation of Sunitinib Treatment at Month 24 Follow-up Visit: mRCC Participants With CR
timeFrame: Month 24 follow-up study visit
measure: Number of Participants Who Discontinued Sunitinib Permanently at Month 24 Follow-up Visit: mRCC Participants With CR
timeFrame: Month 24 follow-up study visit
measure: Number of Participants Categorized According to Reasons for Permanent Discontinuations of Sunitinib Treatment at Month 24 Follow-up Visit: mRCC Participants With CR
timeFrame: Month 24 follow-up study visit
measure: Duration of Treatment With Sunitinib Since Complete Remission at Month 24 Follow-up Visit: mRCC Participants With CR
timeFrame: Month 24 follow-up study visit
measure: Time to Progression With Sunitinib Treatment From Complete Remission: mRCC Participants With CR
timeFrame: From achieving CR with Sunitinib treatment (before inclusion in the study, participants recruited for 3 years) to Visit at progression (during study); [post inclusion follow-up in the study was maximum of 39.8 months for Cases]
measure: Duration of Additional Treatment With Sunitinib Since Complete Remission: mRCC Participants With CR
timeFrame: From complete remission (before inclusion in the study, participants recruited for 3 years) till discontinuation of additional treatment during this study; [post inclusion follow-up in the study was maximum of 39.8 months for Cases]
measure: Number of Participants Categorized According to Types of Progression: mRCC Participants With CR
timeFrame: Study visit at progression; post inclusion follow-up in the study was maximum of 39.8 months for Cases
measure: Number of Participants Categorized According to Site of Progression: mRCC Participants With CR
timeFrame: Study visit at progression; post inclusion follow-up in the study was maximum of 39.8 months for Cases
measure: Number of Participants Categorized According to Location of Metastases: mRCC Participants With CR
timeFrame: Study visit at progression; post inclusion follow-up in the study was maximum of 39.8 months for Cases
measure: Number of Participants Categorized According to Type of Lymph Nodes as Metastatic Site: mRCC Participants With CR
timeFrame: Study visit at progression; post inclusion follow-up in the study was maximum of 39.8 months for Cases
measure: Number of Participants Categorized According to Number of Metastatic Sites: mRCC Participants With CR
timeFrame: Study visit at progression; post inclusion follow-up in the study was maximum of 39.8 months for Cases
measure: Number of Participants Who Received Systemic Treatment After Progression: mRCC Participants With CR
timeFrame: After progression, during follow up period maximum of 39.8 months for Cases
measure: Number of Participants Categorized According to Type of Systemic Treatment Received After Progression: mRCC Participants With CR
timeFrame: After progression, during follow up period maximum of 39.8 months for Cases
measure: Number of Participants With Best Objective Response After Progression: mRCC Participants With CR
timeFrame: At the end of study visit follow-up (during follow up period maximum of 39.8 months for Cases)
measure: Duration of Treatment With First Line Sunitinib Till Progression: mRCC Participants With CR
timeFrame: Sunitinib initiation (before inclusion, participants recruited for 3 years) till progression (follow up period maximum of 39.8 months for Cases)
measure: Number of Participants Who Were Early Terminated: mRCC Participants With CR
timeFrame: From inclusion in the study till termination (during follow up period maximum of 39.8 months for Cases)
measure: Number of Participants Who Achieved Response: mRCC Participants With CR
timeFrame: At initiation of sunitinib (during follow up period maximum of 39.8 months for Cases)
measure: Number of Participants Categorized According to Number of Subsequent Treatment Lines From Progression/Post Complete Remission: mRCC Participants With CR
timeFrame: At initiation of sunitinib (during follow up period maximum of 39.8 months for Cases)
measure: Number of Participants Who Died: mRCC Participants With CR
timeFrame: At initiation of sunitinib (during follow up period maximum of 39.8 months for Cases)
measure: Progression Free Survival: mRCC Participants With CR
timeFrame: At the end of the study (inclusion period was of 3 years and follow up period maximum of 39.8 months for Cases)
measure: Number of Participants With Adverse Events and Serious Adverse Events
timeFrame: During follow up period maximum of 39.8 months for Cases and 37 months for Controls
measure: Number of Participants With Adverse Events and Serious Adverse Events Possibly Related to Drug Exposure
timeFrame: During follow up period maximum of 39.8 months for Cases and 37 months for Controls
measure: Number of AEs According to Action Taken for the Study Treatment in Response to Those AEs
timeFrame: During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Secondary outcomes:
Other outcomes:
measure: Number of Participants Categorized According to Types of Blood Biomarkers
timeFrame: During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Locations:
city: Marseille
country: France
facility: CHU de la Timone
state: Cedex 5
city: Strasbourg
country: France
facility: CHU Strasbourg
state: Cedex
city: Angers Cedex
country: France
facility: CHRU HOTEL DIEU - Service Urologie
city: Brest
country: France
facility: C.H.U Morvan
city: Le Mans
country: France
facility: Clinique Victor Hugo
city: Marseille Cedex 09
country: France
facility: Institut Paoli-Calmettes
city: Marseille Cedex 9
country: France
facility: Institut Paoli-Calmettes / Hôpital de jour
city: Marseille Cedex
country: France
facility: Hopital Timone Adultes
city: Montpellier cedex 05
country: France
facility: CRLC Val d'Aurelle
city: Paris Cedex 15
country: France
facility: Hopital Europeen Georges Pompidou
city: Pierre Bénite Cedex
country: France
facility: Centre Hospitalier Lyon Sud
city: Strasbourg
country: France
facility: Clinique Chirurgicale de l'Orangerie, Chiliotherapie
city: Vandoeuvre les Nancy
country: France
facility: Centre Alexis Vautrin
city: Villejuif Cedex
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: