N/A
Completed N=69
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
Source: ClinicalTrials.gov NCT02187042 ↗Enrolled (actual)
69
Serious AEs
39.1%
Results posted
Oct 2019
Primary outcomePrimary: 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 — 34; 14 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
34; 14 | — |
| SECONDARY Number of Participants With at Least 1 Sunitinib Dose Reduction |
12; 4 | — |
| SECONDARY Number of Participants Involved in at Least 1 Occasion For Each of the Reasons for a Sunitinib Dose Reduction |
12; 3; 0; 1 | — |
| SECONDARY Average Sunitinib Dose Reduction |
12.5; 12.5 | — |
| SECONDARY Number of Participants With at Least 1 Temporary Interruption of Sunitinib Treatment |
27; 8 | — |
| SECONDARY Mean Duration (in Days) of Temporary Interruption to Sunitinib Treatment |
10.5; 16.6 | — |
| SECONDARY Number of Participants Involved on at Least 1 Occasion for Each of the Reasons for a Sunitinib Temporary Treatment Interruption |
19; 7; 1; 0; 4; 0 | — |
| SECONDARY Number of Participants Who Permanently Discontinued Sunitinib Treatment |
13; 14 | — |
| SECONDARY Number of Participants Involved on At Least 1 Occasion for Each of the Reasons for a Permanent Sunitinib Treatment Discontinuation |
4; 8; 6; 5; 1; 0 | — |
| SECONDARY Mean Duration of Sunitinib Treatment |
4.8; 4.2 | — |
| SECONDARY Number of Participants Classified on the Basis of Number of Sunitinib Treatment Cycles |
6; 3; 1; 7; 7; 5 | — |
| SECONDARY Number of Participants With At Least 1 Unplanned Hospitalization |
9 | — |
| SECONDARY Number of Participants With At Least 1 Unplanned Consultation |
16 | — |
| SECONDARY Number of Participants Who Were "Adherent" as Per 4- Item Morisky Medication Adherence Scale (MMAS-4) |
30; 15 | — |
| SECONDARY Mean 4-Item Morisky Medication Adherence Scale (MMAS-4) Score |
0.1; 0.2 | — |
| SECONDARY Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Best Response |
33.3 | — |
| SECONDARY Mean Scores for Each Dimension on the Participant's Satisfaction (With the Management By the Telephone Call Center) Questionnaire |
1.2; 1.1; 1.2; 1.2 | — |
| SECONDARY Number of Participants Who Reported Themselves Being "Satisfied" or "Very Satisfied" With the Management By the Telephone Call Center |
19 | — |
| SECONDARY Mean Scores for Each Dimension on the Physician's Satisfaction (With the Management By the Telephone Call Center) Questionnaire |
0.4; -0.6; 0.1 | — |
| SECONDARY Number of Investigating Physicians Who Reported Themselves Being "Satisfied" or "Very Satisfied" With the Management By the Telephone Call Center |
7 | — |
| SECONDARY Total Number of Calls (Planned and Unplanned) |
431 | — |
| SECONDARY Number of Participants Who Were Taking Sunitinib as Told to Call Center During the First Call |
33 | — |
| SECONDARY Number of Participants With Their Responses as "Yes" Against the Actions of Investigating Physicians, as Told to Call Center During the First Call |
31; 31; 27; 27 | — |
| SECONDARY Number of Telephone Calls Describing Actions Taken by Call Center |
266; 281; 341; 263; 278; 222 | — |
| SECONDARY Number of Telephone Calls Where Participants Declared Adverse Events |
280 | — |
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
Data sourced from ClinicalTrials.gov (NCT02187042). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.