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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 70
- 试验地点
- 13
- 主要终点
- 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
研究概览
简要总结
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).
详细描述
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)..
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
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
时间窗: Baseline up to 6 months
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.
次要结局
- Average Sunitinib Dose Reduction(Baseline up to 6 months)
- Number of Participants With at Least 1 Sunitinib Dose Reduction(Baseline up to 6 months)
- Number of Participants Involved in at Least 1 Occasion For Each of the Reasons for a Sunitinib Dose Reduction(Baseline up to 6 months)
- Number of Participants With at Least 1 Temporary Interruption of Sunitinib Treatment(Baseline up to 6 months)
- Number of Participants Involved on at Least 1 Occasion for Each of the Reasons for a Sunitinib Temporary Treatment Interruption(Baseline up to 6 months)
- Mean Duration of Sunitinib Treatment(Baseline up to 6 months)
- Mean Scores for Each Dimension on the Physician's Satisfaction (With the Management By the Telephone Call Center) Questionnaire(At the end of the study (At Month 6))
- Number of Participants Who Reported Themselves Being "Satisfied" or "Very Satisfied" With the Management By the Telephone Call Center(At the end of the study (At Month 6))
- Number of Investigating Physicians Who Reported Themselves Being "Satisfied" or "Very Satisfied" With the Management By the Telephone Call Center(Baseline up to 6 months)
- Number of Telephone Calls Where Participants Declared Adverse Events(Baseline up to 6 months)
- Mean Duration (in Days) of Temporary Interruption to Sunitinib Treatment(Baseline up to 6 months)
- Number of Participants Who Permanently Discontinued Sunitinib Treatment(Baseline up to 6 months)
- Number of Participants With At Least 1 Unplanned Hospitalization(Baseline up to 6 months)
- Number of Participants With At Least 1 Unplanned Consultation(Baseline up to 6 months)
- Number of Participants Who Were "Adherent" as Per 4- Item Morisky Medication Adherence Scale (MMAS-4)(Baseline up to 6 months)
- Number of Participants Involved on At Least 1 Occasion for Each of the Reasons for a Permanent Sunitinib Treatment Discontinuation(Baseline up to 6 months)
- Number of Participants Classified on the Basis of Number of Sunitinib Treatment Cycles(Baseline up to 6 months)
- Mean 4-Item Morisky Medication Adherence Scale (MMAS-4) Score(Baseline up to 6 months)
- Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Best Response(Baseline up to 6 months)
- Mean Scores for Each Dimension on the Participant's Satisfaction (With the Management By the Telephone Call Center) Questionnaire(At the end of the study (At Month 6))
- Number of Participants Who Were Taking Sunitinib as Told to Call Center During the First Call(First call made anytime from baseline up to 6 months)
- Total Number of Calls (Planned and Unplanned)(Baseline up to 6 months)
- Number of Participants With Their Responses as "Yes" Against the Actions of Investigating Physicians, as Told to Call Center During the First Call(First call made anytime from baseline up to 6 months)
- Number of Telephone Calls Describing Actions Taken by Call Center(Baseline up to 6 months)