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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

Last updated on November 13, 2019

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 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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.

Non-inclusion criteria

- 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 with an ECOG performance status upon inclusion > 2;

- 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

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

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.

Non-inclusion criteria

- 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 with an ECOG performance status upon inclusion > 2;

- 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

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

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Descriptive Information
Brief TitleEvaluation 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 TitleEVALUATION 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
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).

Detailed Description

RENACALL is a prospective intermediate care study whose main aim is to evaluate 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 Sutent®.

100 mRCC patients treated receiving first line Sutent® treatment shall be included in the study, and shall benefit both from conventional follow-up and from additional therapy management platform-based follow-up. Platform follow-up shall consist in regular phone calls to accompany patients in their real life home management of their treatment with sunitinib (prevention, advice and guidance of patients towards options)..

Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationThe 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
ConditionMetastatic/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/CohortsAll patients
Metastatic and/or advanced renal cell carcinoma patients treated with sunitinib in first line and followed by standard care plus call center
Interventions:
  • Other: Best supportive care
  • Other: call center
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 StatusCompleted
Actual Enrollment
 (submitted: July 26, 2018)
70
Original Estimated Enrollment
 (submitted: July 8, 2014)
220
Actual Study Completion DateJuly 25, 2018
Actual Primary Completion DateJuly 25, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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.

Non-inclusion criteria

  • 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 with an ECOG performance status upon inclusion > 2;
  • 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
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesFrance
Removed Location Countries  
 
Administrative Information
NCT NumberNCT02187042
Other Study ID NumbersA6181213
RENACALL ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot 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/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2019

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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