Clinical trial · Observational
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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic/Advanced Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best supportive care | Other | — | UNRESOLVED |
| call center | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- All patients
- description
- Metastatic and/or advanced renal cell carcinoma patients treated with sunitinib in first line and followed by standard care plus call center
- interventionNames
- Other: Best supportive care
- Other: call center
Primary outcomes (1)
- measure
- 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
- timeFrame
- Baseline up to 6 months
- description
- 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.
Secondary outcomes (24)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available