Evaluation Of The Impact Of A Call Center In Management Of Metastatic And/Or Advanced Renal Cell Carcinoma Patients Treated With Sunitinib (Sutent) In First Line
RENACALL
EVALUATION OF THE IMPACT OF A THERAPY MANAGEMENT PLATFORM ON THE MANAGEMENT OF PATIENTS SUFFERING FROM ADVANCED/METASTATIC RENAL CELL CARCINOMA AND RECEIVING FIRST LINE TREATMENT WITH SUNITINIB, VERSUS STANDARD FOLLOW-UP
2 other identifiers
observational
70
1 country
13
Brief Summary
100 patients with metastatic and/or advanced renal cell carcinoma treated with sunitinib (Sutent) will be inclued and followed with standard care plus a call center Principal assumption : the proportion of patients presenting with at least one grade 3 or 4 AE (whether related to sunitinib or not).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2015
Typical duration for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2014
CompletedFirst Posted
Study publicly available on registry
July 10, 2014
CompletedStudy Start
First participant enrolled
October 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 25, 2018
CompletedResults Posted
Study results publicly available
October 24, 2019
CompletedOctober 24, 2019
October 1, 2019
2.8 years
July 8, 2014
July 25, 2019
October 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With at Least 1 Adverse Event (AE) of Grade 3 or 4 Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was death related to AE.
Baseline up to 6 months
Secondary Outcomes (24)
Number of Participants With at Least 1 Sunitinib Dose Reduction
Baseline up to 6 months
Number of Participants Involved in at Least 1 Occasion For Each of the Reasons for a Sunitinib Dose Reduction
Baseline up to 6 months
Average Sunitinib Dose Reduction
Baseline up to 6 months
Number of Participants With at Least 1 Temporary Interruption of Sunitinib Treatment
Baseline up to 6 months
Mean Duration (in Days) of Temporary Interruption to Sunitinib Treatment
Baseline up to 6 months
- +19 more secondary outcomes
Study Arms (1)
All patients
Metastatic and/or advanced renal cell carcinoma patients treated with sunitinib in first line and followed by standard care plus call center
Interventions
BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life
Nurses from a call center will call the patients at regular time to help patients in the management of their cancer, with some dietetic advices, medical advices etc.
Eligibility Criteria
The 100 metastatic and/or advanced patients of the study will come from the population of patients under the care of French renal cell carcinoma oncologists
You may qualify if:
- Man or woman aged 18 or over;
- Patient suffering from a/mRCC, receiving sunitinib first-line treatment, as per SPC recommendations;
- Resolution (grade ≤ 1 according to CTCAE version 4.03 of June 2010) of all acute toxic effects due to radiotherapy or surgical procedure prior to initiation of sunitinib;
- Patient who can be monitored for 6 months.
- Female patient of child-bearing age using a form of contraception during treatment with Sunitinib and for at least 28 days after termination of treatment with Sunitinib;
- Patient having signed his/her consent form;
- Patient affiliated with a social security scheme.
- Patient participating in a clinical trial during sunitinib treatment;
- Patient managed by a home hospitalisation service during sunitinib treatment;
- Patient taking part in therapeutic education programmes, or benefiting from nursing consultation, or from any other significant treatment support and likely to impact adverse event management.
- Patient untreated and/or symptomatic brain metastases prior to sunitinib initiation;
- Patient refusing the use of his/her personal data.
- Patient presenting with a serum creatinine level \>1.5 times the upper limit of the normal level;
- Patient presenting with a bilirubin level \> 2 mg/dl, aspartate transaminase (ASAT) or alanine transaminase (ALAT) \>2.5 times the upper limit of the normal value, or \>5 times the upper limit of the normal value in the presence of liver metastases upon initiation of sunitinib treatment.
- Patients who are staff members of a centre involved in the study, or close to one of the staff members of a centre directly involved in conducting the study, or patients employed by Pfizer and involved in conducting the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (13)
CHU de la Timone
Marseille, Cedex 5, 13335, France
CHU Strasbourg
Strasbourg, Cedex, 67091, France
Centre Hospitalier d'Annecy
Annecy, 74011, France
Centre Catalan Urologie Andrologie
Cabestany, 66330, France
Centre hospitalier de Chambery
Chambéry, 73000, France
Hopital prive La Louviere
Lille, 59042, France
Clinique Claude Bernard Chimiotherapie Ambulatoire
Metz, 57000, France
CRLC Val d'Aurelle
Montpellier, 34295, France
Polyclinique Gentilly
Nancy, 54000, France
Polyclinique de Gentilly Service Oncologie Médicale
Nancy, 54100, France
CHI de Cornouailles - Oncologie hospitalisation
Quimper, 29107, France
Hopital Jean BERNARD - Tours - 7eme etage
Valenciennes, 59300, France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511, France
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2014
First Posted
July 10, 2014
Study Start
October 7, 2015
Primary Completion
July 25, 2018
Study Completion
July 25, 2018
Last Updated
October 24, 2019
Results First Posted
October 24, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.