- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03129724
Retrospective Study in Patients With Metastatic Renal Cancer Treated With TKI Sequence (Tyrosine Kinase Inhibitors of VEGFR) - mTOR- Axitinib Inhibitors or Anti-VEGF Antibody -Inhibiteurs mTOR - Axitinib
April 21, 2017 updated by: University Hospital, Strasbourg, France
Describe in patients with metastatic kidney cancer treatment modalities with the type sequences: TKI - mTORi - Axitinib or VEGF mAb - mTORi - Axitinib.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Philippe Barthélémy, MD
- Phone Number: 33 3 88 11 58 77
- Email: philippe.barthelemy@chru-strasbourg.fr
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
Patient with metastatic kidney cancer (all histological types) Patient has been treated or under treatment with axitinib (Inlyta®) in the third line after the first line of targeted TKI therapy and after mTORi in 2nd line, or Patient receiving the treatment sequence VEGFmAb - mTORi - axitinib
Description
Inclusion criteria:
- Patient with metastatic kidney cancer (all histological types)
- Male or female aged (e) of 18 or more
- Patient has been treated or under treatment with axitinib (Inlyta®) in the third line after the first line of targeted TKI therapy and after mTORi in 2nd line, or
- Patient receiving the treatment sequence VEGFmAb - mTORi - axitinib For living patients: patient informed and having given oral consent
Exclusion criteria:
- Patient who received more than one line of antiangiogenic therapy in the metastatic phase before initiation of treatment with axitinib (except patients in the study Pisces) Patient received a second line treatment with TKI Patient refused to participate in the study
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evolution of Kidney cancer
Time Frame: after surgery, up to 1 year]
|
after surgery, up to 1 year]
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
September 1, 2016
Primary Completion (Anticipated)
July 1, 2017
Study Completion (Anticipated)
July 1, 2017
Study Registration Dates
First Submitted
July 5, 2016
First Submitted That Met QC Criteria
April 21, 2017
First Posted (Actual)
April 26, 2017
Study Record Updates
Last Update Posted (Actual)
April 26, 2017
Last Update Submitted That Met QC Criteria
April 21, 2017
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6154
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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