In mRCC, two therapies are mainly used in first line setting: pazopanib and sunitinib. These two TKI are equally effective in terms of survival however they are responsible for frequent adverse events. Physician mainly use RECIST progression-free survival (PFS) and NCI CTCAE safety as a guide to evaluate treatment efficiency and tolerance. In contrast HRQOL assessment is often restricted to clinical trial. It could be of particular interest to evaluate HRQOL in daily clinical practice in order to adequately choose and manage therapy. Currently the development of Information and Communication Technology may allow HRQOL monitoring in routine practice. The objective of the QUANARIE Study is to evaluate the feasibility of HRQOL assessment in daily clinical practice for patients with mRCC treated with TKI using electronic PRO.
QUANARIE study (NCT03062410) is an interventional, prospective, multicenter trial involving 9 french oncological centers. Patients diagnosed with mRCC initiating TKI anti-VEGF treatment (Sunitinib or Pazopanib) will be invited to complete the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 cancer specific questionnaire and the EQ-5D before each visit with the physician. Questionnaires completion will be done by patients on tablets and/or computer terminals via the CHES software (Computer-based Health Evaluation System) at hospital before consultation or at home via secured portal. Physician will immediately have access to a visual summary of HRQOL evaluation. Primary objective is to assess the feasibility of routine assessment of HRQOL evaluated by the rate of filled questionnaires at 12-months. Key secondary objectives are: exhaustiveness, acceptability and effectiveness. Physician's satisfaction with electronic HRQOL evaluation will be assessed. We hypothesized that 80% of filled questionnaires at 12-months would be meaningful. A sample size of 56 patients would be needed. Enrollment is expected to last for 6 mo. Study started in April 2017. Update will be display on poster during ESMO congress.
Clinical trial identification
Legal entity responsible for the study
University Hospital Jean Minjoz
All authors have declared no conflicts of interest.