Clinical trial NCT01917214: 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
Official title: Patterns Of Care Among Australian Cohort Of Patients With Advanced Rrc Receiving Sutent
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Renal Cell Carcinoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-08-06
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects who are diagnosed with metastatic renal cell carcinoma

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Progression-Free Survival (PFS) From Initiation of Sutent Therapy
timeFrame: From initiation of treatment up to 72 months
Secondary outcomes:
measure: Objective Response Rate - Percentage of Participants With Objective Response From Initiation of Sutent Therapy
timeFrame: From initiation of treatment up to 72 months
measure: Overall Survival (OS)
timeFrame: From diagnosis until death (up to 72 months)
measure: Time to Treatment Failure From Initiation of Sutent Therapy
timeFrame: From initiation of treatment up to 72 months
measure: 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
timeFrame: From initiation of treatment up to 72 months
measure: 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
timeFrame: From initiation of treatment up to 72 months
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: