This pilot study is an open-label interventional study, prospective, non-comparative, sequential (two stages), national, multicenter study. Patients starting therapy with sunitinib or pazopanib as standard first line treatment for advanced or metastatic renal cell carcinoma will enter the study in one of the two cohorts (115 patients will be treated by sunitinib and 99 patients will be treated by pazopanib). The purpose of this study is to examine the feasibility of sunitinib and pazopanib dose individualisation based on therapeutic drug monitoring (TDM) and to assess the benefit of this approach in terms of tolerance and efficacy compared with the current empirical method based only on tolerance observation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
47
CHU DE BORDEAUX - Hôpital Saint-André
Bordeaux, France
Institut Bergonie
Bordeaux, France
CHU DE LIMOGES - Hôpital Dupuytren
Limoges, France
Centre Leon Berard
Lyon, France
Institut Paoli Calmettes
Marseille, France
Institut Regional Du Cancer Montpellier
Montpellier, France
CH RODEZ
Rodez, France
Institut Claudius Regaud
Toulouse, France
Part I: Pharmacokinetics - Pazopanib or Sunitinib plasma concentrations
Time frame: On day 1 and day 15 during cycle 1 and cycle 2 (cycle length is 6 weeks)
Part II: Tolerance - Proportion of patients without treatment discontinuation due to adverse event (AE) during the first year.
This corresponds to the number of patients without treatment discontinuation due to AE among the total number of patients in each group.
Time frame: 5.5 years
Part II: Efficacy - Proportion of patients without progression at 1 year. This corresponds to the number of patients without progression at 1 year among the total number of patients in each group
Time frame: 5.5 years
Part I: Adverse Events according to NCI toxicity scale (version 4.03)
Time frame: 1.5 years
Part I and II: Objective Response (e.g. Complete or Partial Response)
Objective Response will be defined using RECIST Criteria version 1.1.
Time frame: 5.5 years
Part I and II:- Progression free survival.
Progression free survival is defined as the time from inclusion until progression (RECIST Criteria version 1.1) or death. Patients alive at last follow-up news are censored at this date.
Time frame: 5.5 years
Part I and II: Safety according to the classification of the NCI: Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.03.
Time frame: 5.5 years
Part I and II: Hand-foot syndrome (HFS)
Hand-foot syndrome (HFS) will be evaluated using the HFS-14 questionnaire. This scale specifically developed for patients with HFS is a valid and valuable tool for measuring HFS-related QoL impairment.
Time frame: 5.5 years
Part I and II: Quality of life using the quality of life questionnaire (QLQ)-C30
Quality of life will be evaluated using the QLQ-C30 questionnaire
Time frame: 5.5 years
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