Clinical trial NCT03062410: Quality of Life Assessment in Daily Clinical Oncology Practice for Patients With Advanced Renal Cell Carcinoma
Official title: Heath Related Quality of Life Assessment for Patients With Advanced or Metastatic Renal Cell Carcinoma Treated With Tyrosine Kinase Inhibitor Using Electronic Patient Reported Outcome in Daily Clinical Practice.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Carcinoma Metastatic
Kidney Neoplasms
Renal Cancer
Keywords: Health Related Quality of Life
Routine clinical practice
Electronic Patient Reported Outcome
EORTC QLQ-C30
Pazopanib
Sunitinib
Tyrosine Kinase Inhibitor anti-VEGF
Patient Reported Outcome
Supportive Care
Quality of Life
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Physician mainly use RECIST progression-free survival (PFS) and NCI CTCAE safety as a guide to evaluate treatment efficiency. In contrast Health Related Quality of Life (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 first line therapy, especially since HRQOL at diagnosis was shown to be a prognostic factor of overall survival in advanced or metastatic renal cell carcinoma (mRCC). A systematic collection in daily clinical practice of the HRQoL data using standardized questionnaires could strengthen management of symptoms : improve symptom control, improve patient-clinician communication, satisfaction with care and well-being of the patient and in fine the overall survival.

The objective of the QUANARIE Study is to assess the use of HRQOL assessment in daily clinical practice for patients with mRCC treated with tyrosine kinase inhibitor (TKI) using electronic patient reported outcome (PRO).

Indeed, the goal is to make the HRQoL data accessible and exploitable in real time to clinicians, to help medical professionals to optimize their practices by adopting a holistic and personalized approach based on patient reported outcomet.

Detailed description: QUANARIE study 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.

Eligibility criteria: Inclusion Criteria:

* Patient with renal clear cells carcinoma, histologically or cytologically confirmed, locally advanced nonresectable or metastatic who initiate an oral treatment by ITK anti-VEGF (Pazopanib or Sunitinib.)
* Estimated life expectancy over than 3 months.
* Male or female
* Aged 18 years or older
* Patient able to understand French and to complete study questionnaires (no major cognitive disorders)
* Signed informed consent
* Patient affiliated to or beneficiary of French social security regime

Exclusion Criteria:

* Prior systemic treatment for metastatic renal cancer other than immunotherapy. Pretreatment or concomitant treatment with Biphosphonate or Denosumab is allowed.
* Renal carcinoma without clear cell component.
* Psychiatric illness compromising understanding of the information or conducting the study.
* Any acute or chronic disease (eg severe COPD) may affect the patient's ability to receive treatment under study or may make it difficult the interpretation of toxicities or adverse events.
* HIV positive.
* History of active chronic hepatitis including subjects who are carriers of Hepatitis B virus or Hepatitis C virus
* Uncontrolled infection
* History of digestive pathology which could compromise the good absorption of an oral ITK.
* Pregnancy, breast-feeding or absence/refusal of adequate contraception for fertile patients during the period of treatment and for 4 months from the last treatment administration.
* Hypersensitivity or contraindication to any of the study drugs (active substance of ITK or any excipients.)

Primary outcomes:
measure: Rate of filled questionnaires at 12-months
timeFrame: 12 months
Secondary outcomes:
measure: Exhaustiveness
timeFrame: 24 months
measure: Acceptability
timeFrame: 24 months
measure: Effectiveness
timeFrame: 24 months
measure: Physician satisfaction
timeFrame: 12 months
Other outcomes:
measure: Time to occurrence of grade 2 toxicity according to the NCI schedule CTCAE v4
timeFrame: 24 months
measure: Survival under HRQoL deterioration
timeFrame: 24 months
measure: Time to treatment failure (TTF)
timeFrame: 24 months
measure: Progression-free survival (PFS):
timeFrame: 24 months
measure: Overall Survival (OS):
timeFrame: 24 months
Locations:
city: Besançon
country: France
facility: CHU de Besançon
city: Chalon-sur-Saône
country: France
facility: Hôpital privé Sainte Marie
city: Dijon
country: France
facility: Centre de lutte contre le cancer Georges François Leclerc
city: Montbéliard
country: France
facility: Hôpital Nord Franche-Comté
city: Reims
country: France
facility: Centre de lutte contre le cancer Jean Godinot
city: Strasbourg
country: France
facility: Groupe hospitaliser St-Vincent
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
city: Vandœuvre-lès-Nancy
country: France
facility: Centre de lutte contre le cancer Alexis Vautrin - Institut de Cancérologie de Lorraine
Study officials:
affiliation: Centre Hospitalier Universitairede Besançon
name: Guillaume MOUILLET, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mouillet G, Fritzsch J, Paget-Bailly S, Pozet A, Es-Saad I, Meurisse A, Vernerey D, Mouyabi K, Berthod D, Bonnetain F, Anota A, Thiery-Vuillemin A. Health-related quality of life assessment for patients with advanced or metastatic renal cell carcinoma treated with a tyrosine kinase inhibitor using electronic patient-reported outcomes in daily clinical practice (QUANARIE trial): study protocol. Health Qual Life Outcomes. 2019 Feb 4;17(1):25. doi: 10.1186/s12955-019-1085-1.