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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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic Renal Cell Carcinoma

Intervention: Sutent: Observational Study (Other)

Phase: N/A

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

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

Study design: Observational Model: Case-Only, Time Perspective: Retrospective

Primary outcome: Progression-Free Survival (PFS) From Initiation of Sutent Therapy

Secondary outcome:

Objective Response Rate - Percentage of Participants With Objective Response From Initiation of Sutent Therapy

Overall Survival (OS)

Time to Treatment Failure From Initiation of Sutent Therapy

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

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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: August 2013
Last updated: March 13, 2015

Page last updated: August 23, 2015

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