Metastatic Kidney Cancer
Conditions
Brief summary
Patients treated on the first line of Sunitinib-targeted therapy for metastatic kidney cancer. Collection of additional blood tubes during routine blood tests for patient follow-up, to evaluate the plasma concentration of Sunitinib and its active metabolite desethyl-Sunitinib (DES)
Interventions
BIOLOGICALblood sample
blood sample performed on C1D1, C1D14, C2D1, C3D1 and C6D1
Sponsors
University Hospital, Rouen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient at least 18 years old * Patient who read and understood the newsletter and signed the consent form * Renal cell carcinoma histologically proven stage IV * Metastatic stage proven on CT, synchronous or metachronous examination * Patient operated on or not from the primary tumor * Eligible for first-line systemic therapy with Sunitinib-targeted therapy for oncology urology * Affiliation to a social security scheme * Effective contraception (as defined by the WHO) for at least 3 months at the inclusion visit, during treatment and for 1 month after the end of the research (negative pregnancy test) * Postmenopausal woman: confirmatory diagnosis (amenorrhea not clinically induced for more than 12 months at inclusion visit) * General condition WHO 0 to 2 * Life expectancy estimated at more than 6 months at baseline
Exclusion criteria
* Non-metastatic disease * Other cancer proven histologically, or in complete remission for less than 2 years * Contraindication to SUTENT 50 mg hard capsules: Hypersensitivity to the active substance or to any of the excipients * History of immunotherapy treatment for kidney cancer, previous treatment with targeted therapies for the same or previous cancer * Pregnant or lactating woman or wishing to breastfeed within 6 months after the last treatment or no known contraception, * Person deprived of liberty by an administrative or judicial decision or person placed under the protection of justice / sub-guardianship or curatorship * Patient currently involved in an interventional trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib | At the end of Cycle 1 (each cycle is 28 days) | hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib |
| hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib | At the end of Cycle 1 (each cycle is 28 days) | hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| plasma desethyl-Sunitinib (DES) concentration | Cycle1 Day14 (each cycle is 28 days) | influence of plasma DES concentration on patients survival |
| plasma Sunitinib concentration | Cycle1 Day14 (each cycle is 28 days) | influence of plasma Sunitinib concentration on patients survival |
| plasma DES concentration | Cycle1 Day28 (each cycle is 28 days) | influence of plasma Sunitinib concentration on patients survival |
Countries
France
Outcome results
None listed