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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

Last updated on March 14, 2019

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Study Location
CHU de la Timone
Marseille, Cedex 5, 13335 France
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic/Advanced Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-99 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Metastatic and/or advanced renal cell carcinoma patients treated with sunitinib in
first line according to the summary of product characteristics

- Resolution of all adverse event (grade ≤ 1 according to the Common Terminology
Criteria for Adverse Events v 4.3 of June 2010) from a prior treatment by radiotherapy
and/or surgery

- Patient who can be followed for 6 months

- Patient who has signed a consent form

- Patient affiliated to a national health service

- Sexually active fertile subjects and their partners must agree to use medically
accepted methods of contraception during the course of the study and for 28 days after
the last dose of study treatment

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Patient who is participating in another clinical study

- Patient taken in charge by a home help service

- Patient with brain metastases not treated or symptomatic

- Patient with an Eastern Cooperative Oncology Group at inclusion > 2

- Patient with a rate of serum creatinine > 1.5 times the upper limit normal

- Patient with a rate of bilirubin > 2 mg/dl

- Patient with a rate of aspartate transaminase (ASAT) or alanine transaminase (ALAT) >
2.5 times the upper limit normal or > 5 times the upper limit normal for patients with
hepatic metastases

NCT02187042
Pfizer
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

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