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
NCT02187042
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
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
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Marseille, Cedex 5
- Strasbourg, Cedex
- Annecy Cedex,
- Cabestany,
- Chambery,
- Lille,
- Metz,
- Montpellier cedex 05,
- Nancy,
- Nancy,
- Quimper Cedex,
- Valenciennes,
- Vandoeuvre les Nancy,
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 | 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 | ||||
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 Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective | ||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Probability Sample | ||||
Study Population | 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 | ||||
Condition | Metastatic/Advanced Renal Cell Carcinoma | ||||
Intervention |
| ||||
Study Groups/Cohorts | 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:
| ||||
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 | 70 | ||||
Original Estimated Enrollment | 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: Man or woman aged 18 or over;
Non-inclusion criteria
| ||||
Sex/Gender |
| ||||
Ages | 18 Years and older (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 |
| ||||
Responsible Party | Pfizer | ||||
Study Sponsor | Pfizer | ||||
Collaborators | Not Provided | ||||
Investigators |
| ||||
PRS Account | Pfizer | ||||
Verification Date | October 2019 |