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Trial record 1 of 1 for:    NCT02187042
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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)

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ClinicalTrials.gov Identifier: NCT02187042
Recruitment Status : Completed
First Posted : July 10, 2014
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date July 8, 2014
First Posted Date July 10, 2014
Last Update Posted Date February 15, 2019
Actual Study Start Date October 7, 2015
Actual Primary Completion Date July 25, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 8, 2014)
Percentage of patients who presented at least one adverse event of grade 3 or 4 (linked or not to sunitinib) [ Time Frame: 6 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02187042 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 8, 2014)
  • Percentage of patients who needed at least one dose reduction of sunitinib [ Time Frame: 6 months ]
  • Percentage of patients who needed at least one interruption of treatment by sunitinib [ Time Frame: 6 months ]
  • Percentage of patients who discontinued sunitinib before the end of the study [ Time Frame: 6 months ]
  • Percentage of patients who needed unplanned hospitalisations [ Time Frame: 6 months ]
  • Percentage of patients who needed unplanned consultations [ Time Frame: 6 months ]
  • Patient adherence to sunitinib [ Time Frame: Week 6, 12 and 24 ]
    Morisky questionnaire
  • Overall response rate [ Time Frame: 6 months ]
  • Patients and doctors satisfaction to the call center [ Time Frame: 6 months ]
    Self-administered questionnaire
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
Official Title PRAGMATIC STUDY EVALUATING 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
Brief Summary

220 patients with metastatic and/or advanced renal cell carcinoma treated with sunitinib (Sutent) will be randomized into two arms :

  • Control arm: Followed with standard care
  • Experimental arm: Followed with standard care plus a call center

Principal assumption : reduce the percentage of adverse events of grade 3, 4 by 20% between the control arm (60%) and the experimental arm.

Detailed Description

Observational study, prospective that randomized metastatic and/or advanced renal cell carcinoma patients into two arms

  • Control arm: Followed with standard care
  • Experimental arm: Followed with standard care plus a call center All eligible metastatic and/or advanced renal cell carcinoma patients seen by investigators who will participate in the study will be enrolled and randomized into the study. If an eligible patient is not enrolled in the study, the oncologists will have to complete that point in a registry of non inclusion.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The 220 metastatic and/or advanced patients of the study will come from the population of patients under the care of French renal cell carcinoma oncologists
Condition Metastatic/Advanced Renal Cell Carcinoma
Intervention
  • Other: Best supportive care
    BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life
  • Other: call center
    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.
Study Groups/Cohorts
  • Best supportive care
    Metastatic and/or advanced renal cell carcinoma patients treated with sunitinib in first line and followed by standard care
    Intervention: Other: Best supportive care
  • Experimental arm
    Metastatic and/or advanced renal cell carcinoma patients treated with sunitinib in first line and followed by standard care plus call center
    Interventions:
    • Other: call center
    • Other: Best supportive care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 26, 2018)
70
Original Estimated Enrollment
 (submitted: July 8, 2014)
220
Actual Study Completion Date July 25, 2018
Actual Primary Completion Date July 25, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Metastatic and/or advanced renal cell carcinoma patients treated with sunitinib in first line according to the summary of product characteristics
  • Resolution of all adverse event (grade ≤ 1 according to the Common Terminology Criteria for Adverse Events v 4.3 of June 2010) from a prior treatment by radiotherapy and/or surgery
  • Patient who can be followed for 6 months
  • Patient who has signed a consent form
  • Patient affiliated to a national health service
  • Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception during the course of the study and for 28 days after the last dose of study treatment

Exclusion Criteria:

  • Patient who is participating in another clinical study
  • Patient taken in charge by a home help service
  • Patient with brain metastases not treated or symptomatic
  • Patient with an Eastern Cooperative Oncology Group at inclusion > 2
  • Patient with a rate of serum creatinine > 1.5 times the upper limit normal
  • Patient with a rate of bilirubin > 2 mg/dl
  • Patient with a rate of aspartate transaminase (ASAT) or alanine transaminase (ALAT) > 2.5 times the upper limit normal or > 5 times the upper limit normal for patients with hepatic metastases
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02187042
Other Study ID Numbers A6181213
RENACALL ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: 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.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2019