You are here

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

Last updated on December 6, 2018

FOR MORE INFORMATION
Study Location
CHU de la Timone
Marseille, Cedex 5, 13335 France
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic/Advanced Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-99 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT02187042
Pfizer
Completed
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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

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
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

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.

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.
Observational
Observational Model: Other
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
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
Metastatic/Advanced Renal Cell Carcinoma
  • 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.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
186
September 29, 2017
September 29, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
France
 
 
NCT02187042
A6181213
RENACALL ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now