Clinical trial NCT03630692: Safety and Compliance of Renal Cancer Patients Treated by Non-IV Drugs
Official title: Safety and Compliance of Patients Treated With Oral Route Anti Cancer Drugs.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Renal Cancer
Stage III Renal Cell Cancer
Keywords: kidney cancer,
oral drug
safety
adherence
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
Collaborators: name: University of Angers, GRANEM
name: Fondation ARC
First posted: 2018-08-15
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients treated for a metastatic renal cancer by an oral route drug (sunitinib, axitinib, sorafenib, pazopanib, everolimus et cabozantinib) in Bretagne and Pays de la Loire area

Brief summary: Generally, in the trials, an observant patient is described as correctly taking 90 to 100% of the prescribed doses. Here, the 80% compliance rate will be the cut-off between observant and non-observant patients.

The evaluation methodology is based primarily on a survey of patients with metastatic or locally advanced kidney cancer who have just began an oral treatment protocol. The constitution of this cohort will be made from newly treated patients included by oncologists. The survey consists of implementing a series of questionnaires with each patient of the sample throughout the course of oral cancer care.

This series of questionnaires will aim to identify:

* the gradient of compliance of the patient with his treatment,
* all the factors likely to influence positively or negatively the latter, whether medical, material or socio-economic,
* the evolution of patient compliance during their treatment course,
* a patient's quality of life index through the standardized quality of life survey form (EORTC - Quality of Life Questionnaire QLQ C30 version 3).
* These questionnaires will be supplemented by the medical record data (including information on tolerance and possible drug interactions). The representativeness of the patients surveyed will be established by comparing the statistical characteristics of the surveyed population with those of the aggregate anonymous global data obtained by the two Medical Department of the French Regional Health Insurance of the two regions. From the data compiled by this study, different econometric models of patient behavior will seek to establish, in particular, a relationship between the probability that a given patient will be either non or poorly observant and the various variables proved to be statistically significant.

Detailed description: Data obtained from patients via the questionnaires will be copied into a computer database and as follows :

* The date of birth (day, month and year),
* Sex,
* The patient's opinion and attitude towards the current treatment: compliance, adverse effects, lifestyle restrictions, changes in professional activity, family activities, relationships, physical fitness, moral, concomitant treatments, expenses not refunded parallels related to the management of adverse effects,
* The family situation, the number of children,
* Degrees obtained and employment,
* Net monthly income.

In parallel with the questionnaires, the Clinical Research Associate (CRAs) of the Observatory will collect data from the medical file on site. The data collected on an electronic Case Report Form (e-CRF) are as follows:

* Type of cancer, date of diagnosis and metastatic disease, possible surgery and radiotherapy,
* Description of the different treatment lines: number of cures, start and end date, response, toxicities,
* Status of the patient at the end of the study.

The number of subjects needed is calculated from observant patients. Based on the existing literature on adherence to chemotherapy or targeted oral therapy, the observed compliance rate is approximately 80%. However, since this characteristic is the object of this study and therefore not known ex ante, in the calculations of the sample size, the value allowing to obtain the lowest margin of error on the rate of compliance, an estimated prevalence of 50% compliance is used. By setting the risk of the first species at 5%, a confidence level of 95%, it is then necessary to include 132 patients.

In addition, given the difficulty inherent in the questionnaires in collecting all the information, 20% of the data was estimated not to be evaluable. It will therefore be necessary to include 158 patients in the study to reach our goal.

Eligibility criteria: Inclusion Criteria:

* Adult patient
* Patient with metastatic or locally advanced kidney cancer
* Patient initiating for the first time an oral route anticancer drug : Sutent® (sunitinib), Nexavar® (sorafenib), Afinitor® (everolimus), Votrient® (pazopanib) and Inlyta® (axitinib) and Cabometyx® (cabozantinib)
* Patient having signed an informed consent
* Patient treated outside interventional clinical trial

Exclusion Criteria:

* Patient with cancer other than kidney cancer
* Patient with non-extensive kidney cancer
* Patient treated by surgery, radiotherapy and intravenous chemotherapy exclusively
* Patient unable to undergo protocol monitoring
* Patient included in an interventional trial
* Patient refusing a survey at home or having hearing problems
* Other medical conditions that may interfere with the understanding of the informed consent document, with the assessment of tolerance and the response to questionnaires
* Patient with another condition deemed incompatible with the patient's inclusion into the protocol.
* Patient under guardianship or trusteeship, deprived of liberty, underage patient or pregnant woman
* Patient not affiliated with a social security system beneficiary of such a scheme

Primary outcomes:
measure: Study of observant or nonobservant patient behavior via patient questionnaire
timeFrame: 11 months
Secondary outcomes:
measure: Oral route Progression Free Survival evaluation (PFS)
timeFrame: 11 months
measure: Oral route Response rate analysis
timeFrame: 11 months
measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability).
timeFrame: 11 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancérologie de l'Ouest
city: Angers
country: France
facility: CHU
city: Brest
country: France
facility: Clinique Pasteur Saint Esprit
city: Brest
country: France
facility: CHU Morvan
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
city: Le Mans
country: France
facility: Centre Hospitalier
city: Le mans
country: France
facility: Clinique Victor Hugo
city: Nantes
country: France
facility: Centre Catherine de Sienne
city: Quimper
country: France
facility: CHIC Quimper
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Saint Grégoire
country: France
facility: CHP
city: Saint-Malo
country: France
facility: Centre Hospitalier
city: Saint-Nazaire
country: France
facility: Clinique Mutualiste de l'Estuaire
city: Vannes
country: France
facility: CHP Océane
Study officials:
affiliation: Institut de Cancérologie de l'Ouest
name: Francoise GRUDE, Pharmacist
role: PRINCIPAL_INVESTIGATOR
References: