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 (RENACALL)

Pfizer

Status

Completed

Conditions

Metastatic/Advanced Renal Cell Carcinoma

Treatments

Other: Best supportive care

Other: call center

Study type

Observational

Funder types

Industry

Identifiers

NCT02187042

RENACALL (Other Identifier)

A6181213

Details and patient eligibility

About

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 proportion of patients presenting with at least one grade 3 or 4 AE (whether related to sunitinib or not).

Full 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 carcinoma and receiving first line treatment with Sutent®.

100 mRCC patients treated receiving first line Sutent® treatment shall be included in the study, and shall benefit both from conventional follow-up and from additional therapy management platform-based follow-up. Platform follow-up shall consist in regular phone calls to accompany patients in their real life home management of their treatment with sunitinib (prevention, advice and guidance of patients towards options)..

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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