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Completed

NCT Number: 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

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.

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Key information

Conditions

Metastatic Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sutent: observational study

Other

Sutent oral therapy

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 6, 2013
Registry last updated
Mar 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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