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

March 13, 2015 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

212

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All subjects who are diagnosed with metastatic renal cell carcinoma

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-Interventional Study
Other: Sutent: Observational Study
Sutent oral therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS) From Initiation of Sutent Therapy
Time Frame: From initiation of treatment up to 72 months
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate - Percentage of Participants With Objective Response From Initiation of Sutent Therapy
Time Frame: From initiation of treatment up to 72 months
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
Overall Survival (OS)
Time Frame: From diagnosis until death (up to 72 months)
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 Frame: From initiation of treatment up to 72 months
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
Time Frame: From initiation of treatment up to 72 months
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
Time Frame: From initiation of treatment up to 72 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

July 25, 2013

First Submitted That Met QC Criteria

August 2, 2013

First Posted (Estimate)

August 6, 2013

Study Record Updates

Last Update Posted (Estimate)

March 26, 2015

Last Update Submitted That Met QC Criteria

March 13, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6181210

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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