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

220 patients with metastatic and/or advanced renal cell carcinoma treated with sunitinib (Sutent) will be randomized into two arms :

• Control arm: Followed with standard care
• Experimental arm: Followed with standard care plus a call center

Principal assumption : reduce the percentage of adverse events of grade 3, 4 by 20% between the control arm (60%) and the experimental arm.

Observational study, prospective that randomized metastatic and/or advanced renal cell carcinoma patients into two arms

• Control arm: Followed with standard care
• Experimental arm: Followed with standard care plus a call center All eligible metastatic and/or advanced renal cell carcinoma patients seen by investigators who will participate in the study will be enrolled and randomized into the study. If an eligible patient is not enrolled in the study, the oncologists will have to complete that point in a registry of non inclusion.

• Other: Best supportive care
  
  BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life
• Other: call center
  
  Nurses from a call center will call the patients at regular time to help patients in the management of their cancer, with some dietetic advices, medical advices etc.

• Best supportive care
  
  Metastatic and/or advanced renal cell carcinoma patients treated with sunitinib in first line and followed by standard care
  Intervention: Other: Best supportive care
• Experimental arm
  
  Metastatic and/or advanced renal cell carcinoma patients treated with sunitinib in first line and followed by standard care plus call center
  Interventions:
  

  • Other: call center
  • Other: Best supportive care

Inclusion Criteria:

• 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:

• 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