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This is a retrospective, non-interventional study which looks at the cohort of Renal Cell Carcinoma patients in a real life clinical setting and analyses into factors why these patients have been surviving for as long as 3-5 years unlike Clinical study where the survival is around 2 years.
The factors which will be analysed include patient characteristics, dosage and adverse event management and tries to correlate these factors with survival.
A single cohort of 200 patients who are diagnosed with metastatic renal cell carcinoma prior to 1st Jan 2012, and are seen by the medical oncologist at the centers involved with BIOGRID and its affiliated registries. Patients will be identified from the first date of their consultation with the medical oncologist and captured in the electronic database. Consent to use datasets has already been obtained from participating research institutes and hospitals IRB/Ethics Committees
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Interventional Study |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sutent: Observational Study | Other | Sutent oral therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) From Initiation of Sutent Therapy | PFS was defined as the time from initiation of Sutent (sunitinib malate) to first documentation of tumor progression or to death due to any cause, whichever occurred first. Time to treatment failure was used as a surrogate for PFS as PFS could not be determined due to retrospective nature of this study. | From initiation of treatment up to 72 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate - Percentage of Participants With Objective Response From Initiation of Sutent Therapy | Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) as per clinical and radiological documentation in clinical notes. CR was defined as complete resolution of all visible disease, whereas PR was defined as partial reduction in size of visible disease. |
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Inclusion Criteria:
Exclusion Criteria:
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All subjects who are diagnosed with metastatic renal cell carcinoma
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Metastatic Renal Cell Carcinoma (mRCC) Cohort | Participants diagnosed with mRCC who received either systemic therapy (Sutent [sunitinib malate] 25 milligram [mg], 37.5 mg or 50 mg or other systemic drugs [like bevacizumab, everolimus, pazopanib, sorafenib, temsirolimus]) OR best supportive care (BSC) as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| From initiation of treatment up to 72 months |
| Overall Survival (OS) | Overall survival was the duration from diagnosis of disease to death. Overall survival was compared for those who had received best supportive care to those who received Sutent as first-line therapy. | From diagnosis until death (up to 72 months) |
| Time to Treatment Failure From Initiation of Sutent Therapy | Time to treatment failure was defined as the time from initiation of study treatment to the date of the first documentation of Progressive Disease (PD), symptomatic deterioration, death due to any cause, or discontinuation of treatment due to AE, refusal or other reason. PD was defined as an increase in visible disease. | From initiation of treatment up to 72 months |
| Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy | Number of participants with CR, PR, SD and PD responses assessed as per clinical and radiological documentation in clinical notes for different Sutent doses were reported. CR was defined as complete resolution of all visible disease, PR was defined as partial reduction in size of visible disease, SD was defined as no change in size of visible disease, and PD was defined as an increase in visible disease. Here "other" refers to Sutent 12.5 mg. | From initiation of treatment up to 72 months |
| Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy | Number of participants with CR, PR, SD and PD responses assessed as per clinical and radiological documentation in clinical notes for different durations of treatment with Sutent were reported. CR was defined as complete resolution of all visible disease, PR was defined as partial reduction in size of visible disease, SD was defined as no change in size of visible disease, and PD was defined as an increase in visible disease. | From initiation of treatment up to 72 months |
| COMPLETED |
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| NOT COMPLETED |
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Analysis population included participants diagnosed with metastatic renal cell carcinoma (mRCC) during the time period between 1 January 2006 and 31 December 2011.
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| ID | Title | Description |
|---|---|---|
| BG000 | Metastatic Renal Cell Carcinoma (mRCC) Cohort | Participants diagnosed with mRCC who received either systemic therapy (Sutent [sunitinib malate] 25 milligram [mg], 37.5 mg or 50 mg or other systemic drugs [like bevacizumab, everolimus, pazopanib, sorafenib, temsirolimus]) OR best supportive care (BSC) as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age data was available for only 211 participants because 1 participant did not have date of diagnosis captured in the database and hence was excluded from the median age calculation. | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-Free Survival (PFS) From Initiation of Sutent Therapy | PFS was defined as the time from initiation of Sutent (sunitinib malate) to first documentation of tumor progression or to death due to any cause, whichever occurred first. Time to treatment failure was used as a surrogate for PFS as PFS could not be determined due to retrospective nature of this study. | Time to treatment failure (given in outcome measure 4) was used as a surrogate for PFS due to the lack of consistent regular restaging scans in clinical practice. | Posted | From initiation of treatment up to 72 months |
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| Secondary | Objective Response Rate - Percentage of Participants With Objective Response From Initiation of Sutent Therapy | Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) as per clinical and radiological documentation in clinical notes. CR was defined as complete resolution of all visible disease, whereas PR was defined as partial reduction in size of visible disease. | Participants diagnosed with mRCC during the time period between 1 January 2006 and 31 December 2011 and received Sutent as a first-line therapy. | Posted | Number | percentage of participants | From initiation of treatment up to 72 months |
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| Secondary | Overall Survival (OS) | Overall survival was the duration from diagnosis of disease to death. Overall survival was compared for those who had received best supportive care to those who received Sutent as first-line therapy. | Participants diagnosed with mRCC during time period between 1 January 2006 and 31 December 2011 and received Sutent or Best Supportive Care as a first-line therapy. Here, "N" (number of participants analyzed)=participants who were evaluable for this outcome measure. "n"=participants who were evaluable for this measure for each specified treatment. | Posted | Median | 95% Confidence Interval | months | From diagnosis until death (up to 72 months) |
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| Secondary | Time to Treatment Failure From Initiation of Sutent Therapy | Time to treatment failure was defined as the time from initiation of study treatment to the date of the first documentation of Progressive Disease (PD), symptomatic deterioration, death due to any cause, or discontinuation of treatment due to AE, refusal or other reason. PD was defined as an increase in visible disease. | Participants diagnosed with mRCC during the time period between 1 January 2006 and 31 December 2011 and received Sutent as a first-line therapy. Here, "N" (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | months | From initiation of treatment up to 72 months |
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| Secondary | Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy | Number of participants with CR, PR, SD and PD responses assessed as per clinical and radiological documentation in clinical notes for different Sutent doses were reported. CR was defined as complete resolution of all visible disease, PR was defined as partial reduction in size of visible disease, SD was defined as no change in size of visible disease, and PD was defined as an increase in visible disease. Here "other" refers to Sutent 12.5 mg. | Participants diagnosed with mRCC during the time period between 1 January 2006 and 31 December 2011 and received Sutent as a first-line therapy. Here, "n" signifies those participants who were evaluable for this measure for specified Sutent treatment. | Posted | Number | participants | From initiation of treatment up to 72 months |
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| Secondary | Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy | Number of participants with CR, PR, SD and PD responses assessed as per clinical and radiological documentation in clinical notes for different durations of treatment with Sutent were reported. CR was defined as complete resolution of all visible disease, PR was defined as partial reduction in size of visible disease, SD was defined as no change in size of visible disease, and PD was defined as an increase in visible disease. | Participants diagnosed with mRCC during the time period between 1 January 2006 and 31 December 2011 and received Sutent as a first-line therapy. Here, "n" signifies those participants who were evaluable for this measure for specified treatment duration. | Posted | Number | participants | From initiation of treatment up to 72 months |
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Due to the retrospective nature of this study, adverse events (AEs) were not collected for this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metastatic Renal Cell Carcinoma (mRCC) Cohort | Participants diagnosed with mRCC who received either systemic therapy (Sutent [sunitinib malate] 25 milligram [mg], 37.5 mg or 50 mg or other systemic drugs [like bevacizumab, everolimus, pazopanib, sorafenib, temsirolimus]) OR best supportive care (BSC) as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively. | 0 | 0 | 0 | 0 |
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Due to retrospective nature of this study, PFS could not be determined as restaging scans are not done on a consistent and regular basis in clinical practice. Time to treatment failure was used as a surrogate for PFS.
Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days.
Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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