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Quality of Life Assessment in Daily Clinical Oncology Practice for Patients With Advanced Renal Cell Carcinoma (QUANARIE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03062410
Recruitment Status : Unknown
Verified July 2018 by Centre Hospitalier Universitaire de Besancon.
Recruitment status was:  Recruiting
First Posted : February 23, 2017
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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.


Condition or disease Intervention/treatment Phase
Renal Carcinoma Metastatic Kidney Neoplasms Renal Cancer Other: Electronic PRO in daily clinical practice Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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.
Actual Study Start Date : May 4, 2017
Estimated Primary Completion Date : November 4, 2019
Estimated Study Completion Date : February 4, 2020


Arm Intervention/treatment
Electronic PRO
All 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.
Other: Electronic PRO in daily clinical practice
All 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 Outcome Measures :
  1. Rate of filled questionnaires at 12-months [ Time Frame: 12 months ]
    Number of completed questionnaires compared to the number of consultations carried out during the first 12 months of follow-up.


Secondary Outcome Measures :
  1. Exhaustiveness [ Time Frame: 24 months ]
    Number of new cases for each center, initiating a treatment per ITK molecule compared to the number of patients to whom the intervention was proposed

  2. Acceptability [ Time Frame: 24 months ]
    Number of patients who agreed to participate in this study compared to the number of refusals on all patients, by center and by molecule type (Sunitinib or Pazopanib)

  3. Effectiveness [ Time Frame: 24 months ]
    Description of the toxicities collected by physicians according to the NCI CTCAE V4 compared to the toxicities reported by patients according to the 8 symptomatic dimensions of the QLC-C30 questionnaire and 9 items from EORTC Item Bank exploring 6 supplementary symptomatic dimensions

  4. Physician satisfaction [ Time Frame: 12 months ]

Other Outcome Measures:
  1. Time to occurrence of grade 2 toxicity according to the NCI schedule CTCAE v4 [ Time Frame: 24 months ]
    Defined as the time elapse between the inclusion date and the date of occurrence of grade 2 toxicity.

  2. Survival under HRQoL deterioration [ Time Frame: 24 months ]
    Assessed by the QLQ-C30 questionnaire and defined by the time between the inclusion date and the first clinically significant minimal deterioration (MCID) at the baseline score without clinically significant improvement or death from any cause

  3. Time to treatment failure (TTF) [ Time Frame: 24 months ]
    Defined as the time interval between the date of inclusion and death, tumor progression or definitive cessation of TKI treatment from any cause.

  4. Progression-free survival (PFS): [ Time Frame: 24 months ]
    Defined as the time interval between the date of inclusion and the date of first progression of the disease or death from any cause.

  5. Overall Survival (OS): [ Time Frame: 24 months ]
    Defined as the time interval between the date of inclusion and the date of death from any cause.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03062410


Contacts
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Contact: Guillaume MOUILLET, MD 0033370632266 gmouillet@chu-besancon.fr
Contact: Astrid POZET 0033370632179 apozet@chu-besancon.fr

Locations
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France
CHU de Besançon Active, not recruiting
Besançon, France, 25030
Hôpital privé Sainte Marie Recruiting
Chalon-sur-Saône, France, 71100
Contact: Erika Viel, MD    0033385488989      
Centre de lutte contre le cancer Georges François Leclerc Recruiting
Dijon, France, 21000
Contact: Sylvain Ladoire, MD    0033380737506    sladoire@cgfl.fr   
Hôpital Nord Franche-Comté Recruiting
Montbéliard, France, 25200
Contact: Guillaume Mouillet, MD       mouillet.guillaume@gmail.com   
Centre de lutte contre le cancer Jean Godinot Recruiting
Reims, France, 51100
Contact: Jean-Christophe Eymard, MD         
Groupe hospitaliser St-Vincent Recruiting
Strasbourg, France, 67000
Contact: Louis-Marie Dourthe, MD       lm.dourthe@solcrr.org   
Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67000
Contact: Philippe Barthelemy, MD       philippe.barthelemy@chru-strasbourg.fr   
Centre de lutte contre le cancer Alexis Vautrin - Institut de Cancérologie de Lorraine Recruiting
Vandœuvre-lès-Nancy, France, 54519
Contact: Lionnel Geoffrois, MD       l.geoffrois@nancy.unicancer.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Guillaume MOUILLET, MD Centre Hospitalier Universitairede Besançon
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03062410    
Other Study ID Numbers: R/2016/54
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Besancon:
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
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases