Status:
COMPLETED
Evaluation Of The Impact Of A Call Center In Management Of Metastatic And/Or Advanced Renal Cell Carcinoma Patients Treated With Sunitinib (Sutent) In First Line
Lead Sponsor:
Pfizer
Conditions:
Metastatic/Advanced Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Brief Summary
100 patients with metastatic and/or advanced renal cell carcinoma treated with sunitinib (Sutent) will be inclued and followed with standard care plus a call center Principal assumption : the proport...
Detailed Description
RENACALL is a prospective intermediate care study whose main aim is to evaluate the impact of a therapy management platform on the management of patients suffering from advanced/metastatic renal cell ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Man or woman aged 18 or over;
- Patient suffering from a/mRCC, receiving sunitinib first-line treatment, as per SPC recommendations;
- Resolution (grade ≤ 1 according to CTCAE version 4.03 of June 2010) of all acute toxic effects due to radiotherapy or surgical procedure prior to initiation of sunitinib;
- Patient who can be monitored for 6 months.
- Female patient of child-bearing age using a form of contraception during treatment with Sunitinib and for at least 28 days after termination of treatment with Sunitinib;
- Patient having signed his/her consent form;
- Patient affiliated with a social security scheme.
- Non-inclusion criteria
- Patient participating in a clinical trial during sunitinib treatment;
- Patient managed by a home hospitalisation service during sunitinib treatment;
- Patient taking part in therapeutic education programmes, or benefiting from nursing consultation, or from any other significant treatment support and likely to impact adverse event management.
- Patient untreated and/or symptomatic brain metastases prior to sunitinib initiation;
- Patient refusing the use of his/her personal data.
- Patient with an ECOG performance status upon inclusion \> 2;
- Patient presenting with a serum creatinine level \>1.5 times the upper limit of the normal level;
- Patient presenting with a bilirubin level \> 2 mg/dl, aspartate transaminase (ASAT) or alanine transaminase (ALAT) \>2.5 times the upper limit of the normal value, or \>5 times the upper limit of the normal value in the presence of liver metastases upon initiation of sunitinib treatment.
- Patients who are staff members of a centre involved in the study, or close to one of the staff members of a centre directly involved in conducting the study, or patients employed by Pfizer and involved in conducting the study
Exclusion
Key Trial Info
Start Date :
October 7 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 25 2018
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT02187042
Start Date
October 7 2015
End Date
July 25 2018
Last Update
October 24 2019
Active Locations (13)
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1
CHU de la Timone
Marseille, Cedex 5, France, 13335
2
CHU Strasbourg
Strasbourg, Cedex, France, 67091
3
Centre Hospitalier d'Annecy
Annecy, France, 74011
4
Centre Catalan Urologie Andrologie
Cabestany, France, 66330