NCT01917214

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2013

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2013

Completed
7 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 26, 2015

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

7 months

First QC Date

July 25, 2013

Results QC Date

March 13, 2015

Last Update Submit

March 13, 2015

Conditions

Metastatic Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

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

    From initiation of treatment up to 72 months

  • Overall Survival (OS)

    From diagnosis until death (up to 72 months)

  • Time to Treatment Failure From Initiation of Sutent Therapy

    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

    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

    From initiation of treatment up to 72 months

Study Arms (1)

Non-Interventional Study

Other: Sutent: Observational Study

Interventions

Sutent: Observational StudyOTHER

Sutent oral therapy

Non-Interventional Study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All subjects who are diagnosed with metastatic renal cell carcinoma

You may qualify if:

  • 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

You may not qualify if:

  • No referral to medical oncologist
  • No record available in electronic database

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Limitations and Caveats

Due to retrospective nature of this study, PFS could not be determined as restaging scans are not done on a consistent and regular basis in clinical practice. Time to treatment failure was used as a surrogate for PFS.

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2013

First Posted

August 6, 2013

Study Start

August 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 26, 2015

Results First Posted

March 26, 2015

Record last verified: 2015-03