A Retrospective Real World Analysis Of Sutent In Patients With Metastatic Renal Cell Carcinoma In Community And Academic Centers To Assess The Impact Of Dose Variation On Duration Of Response And Overall Survival

Metastatic Renal Cell Carcinoma Clinical Trial

Official title:

Patterns Of Care Among Australian Cohort Of Patients With Advanced Rrc Receiving Sutent

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01917214
• Other study ID #: A6181210
• Status: Completed
• Phase: N/A
• First received: July 25, 2013
• Last updated: March 13, 2015
• Start date: August 2013
• Est. completion date: March 2014

Study information

• Verified date: March 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18

• Male or female

• Metastatic renal cell cancer

• First presentation with metastatic disease prior to 1st Jan 2012 since 2006, i.e. between 1st Jan 2006 to 31st Dec 2011

Exclusion Criteria:

• No referral to medical oncologist

• No record available in electronic database

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Metastatic Renal Cell Carcinoma

Intervention

Other:
• Sutent: Observational Study
Sutent oral therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	From initiation of treatment up to 72 months	No
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.	From initiation of treatment up to 72 months	No
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.	From diagnosis until death (up to 72 months)	No
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.	From initiation of treatment up to 72 months	No
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.	From initiation of treatment up to 72 months	No
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.	From initiation of treatment up to 72 months	No

External Links

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