With the advent of immunotherapy, standard first-line treatment for patients with renal cell carcinoma is now an association with an immune checkpoint inhibitor. In this context, the association axitinib plus pembrolizumab has already been evaluated in several studies with positive results for Progression Free survival, Overall survival and Complete response. The combo received a positive opinion from the Committee for Medicinal Products for Human Use, and the European Commission approves the extension of Marketing Authorization in first line for metastatic renal cell carcinoma patients. In a context of treatment with a new association, it is important to manage the toxicities closely in order to allow the patients to have an optimal treatment. The underlying hypothesis is that the use of new information and communication technologies could improve clinical patient management. In this study, we wish assess the impact of monitoring via the web application KidneyPRO on the quality of life of patients with the new combination of treatment axitinib/pembrolizumab for a renal cell carcinoma in first line.
Metastatic or locally advanced clear cell renal carcinomas (RCC) are treated with targeted therapies (inhibitors of tyrosine kinases) and immune check-points inhibitors. In first line many combos are tested. Association of TKI-PD L1-inhibitor is one option. Axitinib-Pembrolizumab showed very high response rate and progression free survival compared to Sunitinib but immunotherapies have a specific adverse event profile. Actually, there is no standardized follow-up for this type of treatment. It is important to develop new strategies that reduce the resources used while improving the performance of this surveillance for the benefit of patients, to improve the comfort of patients, to improve the compliance and to optimise the dose of treatment received, in a course of care reworked by maintaining a continuous contact not demanding. In collaboration with the Scientific Research National Center, the theory of chaos and its derivatives was applied to cancer and a web-application was developed on these concepts to remotely analyze the dynamics of the symptoms felt by the patient and early detect a recurrence or a complication of his cancer. Clinical symptoms are self-assessed by patients once a week, transcribed on their smartphone or computer through the Internet application. Relevant clinical events are detected using data processing algorithms, combining the dynamics of the various reported symptoms. In this case, an alert message is sent to the health care team. The referring oncologist is thus warned early. He can then make a telephone call to the patient about the reality of the medical alert and summon him for a check-up or any other complementary examination. Applied to lung cancer, this application is a tried-and-tested solution with a phase III clinical trial. The main criteria was overall survival. The monitoring of these patients with the web-application and with a number of scanners reduced by 50% compared to the reference arm, made it possible to diagnose relapses earlier, to treat them under better conditions and, above all, to improve statistically significant overall survival (a gain in overall survival of 26% at 1 year (in patients intending to treat): 49% in the standard arm versus 75% in the experimental arm: p = 0.0025. This profit persists with 2 years of decline (a median gain in overall survival of 7.6 months, p=0.0312). This concept was confirmed in the NCT0578006 study published by Basch et al. Basch used a similar application during chemotherapy treatment in 766 cancer patients. The web-application has improved overall survival by 5 months (Hazard ratio: 0.83). This web-application provided a statistical improvement in the quality of life for lung cancer, access to new therapeutic lines (74% versus 33%, p \<0.001) and optimally with treatments delivered at therapeutic doses (in 76% versus 34%) and faster access to supportive care for a clear improvement in the general condition of patients (77 versus 33%, p \<0.001). The key for these patients who experienced many treatment toxicities was to use a better method of active follow-up. A real-time survey of quality of life of Renal Cell Cancer patients receiving Axitinib/Pembrolizumab is an objective that has never been evaluated. This study will allow to generate data in patients who were not included in the phase III study (KEYNOTE 426): Performance Status =2, with central nervous system metastasis and with renal insufficiency. Personalized monitoring of these patients with the web-application KidneyPRO is even more relevant because the aim would be to quickly provide care adapted to adverse events, supportive care in case of loss of activity… The web-application KidneyPRO investigated has been developed for this purpose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
178
Web-application for symptoms assessment
usual follow-up
Institut de Cancérologie de l'Ouest
Angers, France
NOT_YET_RECRUITINGCHU Jean Minjoz
Besançon, France
NOT_YET_RECRUITINGClilnique Pasteur
Brest, France
RECRUITINGCHRU Brest
Brest, France
NOT_YET_RECRUITINGCentre François Baclesse
Caen, France
NOT_YET_RECRUITINGCHD Vendée
La Roche-sur-Yon, France
RECRUITINGClinique Victor Hugo / Centre Jean Bernard
Le Mans, France
RECRUITINGCentre Léon Bérard
Lyon, France
NOT_YET_RECRUITINGInstitut Jean Godinot
Reims, France
RECRUITINGCHP St Grégoire
Saint-Grégoire, France
RECRUITING...and 3 more locations
symtom specific Quality Of Life at 24 weeks
difference of 4 points of the Quality Of Life, between the two arms, by the FACT-Kidney Symptom Index (FKSI-19) 24 weeks (6 months) after the first treatment administration date. Higher score is worse.
Time frame: 6 months
Overall survival
Calculated from the date of randomization to the date of death due to any cause or the date last known to be alive if patient is censored.
Time frame: 2 years
Progression Free survival
Calculated from the date of start of treatment to the date of first progression of disease based on Investigator assessment or the date of death or censored at the date of the last valid tumor assessment before start of a new therapy for patients who are still alive and without progression
Time frame: 2 years
Treatment Free Survival
Evaluated from the date of last administration of treatment to the date of the first administration of the next line of treatment or the date last known to be alive if patient is censored
Time frame: 2 years
Duration Of Response
Evaluated from the date of the first documented tumor response to the date of disease progression or the date last known to be alive if patient is censored
Time frame: 2 years
Change From Baseline in FACT-Kidney Symptom Index (FKSI)-19
TThe FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains- Disease Related Symptoms (physical and emotional), Treatment related side effects and Functional and Well-Being . A negative change from Baseline represents a worsening of condition.
Time frame: 2 years
Change From Baseline in Quality Of life Questionnaire-C30 (QLQ-C30)
QLQ-C30 is a generic questionnaire for cancer patients. Score will be calculated according to European Organisation for Research and Treatment of Cancer guidelines for QLQ-C30. . QoL with QLQ-C30 will be evaluated before start of treatment and every 3 months until 24 months and at the end of treatment. A negative change from Baseline represents a worsening of condition.
Time frame: 2 years
Number of patients who experienced an adverse event (AE)
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented.
Time frame: 2 years
Duration of the treatment
Calculated from the date of the first administration of the treatment until the last administration of the last treatment in progress
Time frame: 2 years
Time to treatment discontinuation/failure due to toxicity
Calculated from the date of the first administration of the treatment until the date of the first discontinuation / failure due to toxicity of one of the 2 molecules
Time frame: 2 years
Description of subsequent cancer treatments
Names of subsequant cancer treatments
Time frame: 2 years
Web-application compliance
evaluated by the following ratio: the number of completed questionnaires made via the app verus the theoretical number of questionnaires that the included patients should have complete during a given period
Time frame: 2 years
Treatment compliance
Evaluated by the number of taken tablets verus.the theoretical number of tablets the patient should have taken during a given period
Time frame: 2 years
Sensibility of the application
Evaluated the number of events diagnosed by the app on the number of events that occurred in total.
Time frame: 2 years
Patient web-application satisfaction
Evaluated by a specific self-evaluation at the 6th and 12th month follow-up visits (specific questionnaire dedicated to the use of the web-application) and at the end of treatment
Time frame: 1 year
Performance Status at the end of treatment
Evaluated with the Eastern Cooperative Oncology Group's recommendations, at each visit
Time frame: 2 years
Medical team web-application satisfaction
Evaluated with a specific questionnaire at 12 months.
Time frame: 1 year
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