Non-Interventional Study (NIS) In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With SUTENT®

Study Overview
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Brief Summary
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Primary objective: to increase knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of SUTENT®. Secondary objectives: treatment response, hypothyroidism prevalence.The efficacy will be assessed using the Objective Response Rate, Time to Progression based on the RECIST criteria and the ECOG performance data.

Detailed Description
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180 patients will be enrolled at 20 key oncological centres, the sample size is sufficient for exploratory analysis.

Official Title
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Non-Interventional Study In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With SUTENT®

Conditions
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Metastatic Renal Cell Carcinoma

Intervention / Treatment
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* Drug: SUTENT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with advanced or metastatic renal cell carcinoma. Exclusion Criteria: No previous cytokines therapy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients treated with SUTENT®<br>Patients with metastatic or advanced renal cell carcinoma after failure of cytokines therapy. | Drug: SUTENT<br>* SUTENT® hard gelatin capsules containing 12.5 mg, 25 mg or 50 mg equivalent of sunitinib malate; daily dosage of 50 mg for 4 consecutive weeks followed by a 2-week rest period. Sutent is administered until disease progression or occurrence of unacceptable toxicity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Objective Response | Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR). CR is defined as the disappearance of all target lesions. PR is defined as at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. | 12 months | 
| Progression-free Survival (PFS) | The period from study entry until disease progression, death, or date of last contact. | Baseline to measured progressive disease (up to 12 months) | 
| Overall Survival (OS) | OS is the duration from enrollment to death. | Baseline to date of death (up to 12 months) | 
| Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Week 6 | Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in Not reported category were on study, had no data for this time point. | Week 6 | 
| Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 3 | Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in Not reported category were on study, had no data for this time point. | Month 3 | 
| Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 6 | Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in Not reported category were on study, had no data for this time point. | Month 6 | 
| Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 9 | Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in Not reported category were on study, had no data for this time point. | Month 9 | 
| Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 12 | Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in Not reported category were on study, had no data for this time point. | Month 12 | 
| Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (PFS) | Sunitinib-induced hypertension was determined using blood pressure recorded at each postbaseline visit. Once participants were identified as having sunitinib-induced hypertension, they retained that status at subsequent visits. PFS is the time from start of study treatment to first documentation of tumor response to treatment. Hazard ratio represents the relationship between sunitinib-induced hypertension and PFS (presence/absence of hypertension). | Baseline to date of first documentation of response to treatment (up to 12 months) | 
| Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (OS) | Sunitinib-induced hypertension was determined using blood pressure recorded at each postbaseline visit. Once participants were identified as having sunitinib-induced hypertension, they retained that status at subsequent visits. OS is the time from start of study treatment to death. Hazard ratio represents the relationship between sunitinib-induced hypertension and OS. | Baseline to date of death (up to 12 months) | 
| Percentage of Participants With Hypothyroidism | TSH and FT4 levels were measured and hypothyroidism was defined as a TSH level >5.0 mIU/L at that time point. | Baseline, Months 3, 6, 9, 12 | 
| Percentage of Participants With Hypertension | Hypertension was defined as follows. Grade 1: Asymptomatic, transient (less than [<]24 hours) increase by >20mm Hg (diastolic) or to >150/100 mm Hg if previously within normal limits (WNL). Grade 2: Recurrent or persistent (24 hours or more) or symptomatic increase by >20 mm Hg (diastolic) or to >150/100 mm Hg if previously WNL. Grade 3: Requiring >1 drug or more intensive therapy than previously. Grade 4: Life-threatening. Grade 5: Death. | Baseline, Week 6, Months 3, 6, 9, 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety and tolerability of SUTENT® in patients with metastatic or advanced renal cell carcinoma after failure of cytokines in real-life setting.