Metastatic/Advanced Renal Cell CarcinomaRENACALLNCT02187042
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
An observational study of Metastatic/Advanced Renal Cell Carcinoma, run by Pfizer at 13 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic/Advanced Renal Cell Carcinoma
- What is being tested?
- call center
- How many people
- 70 participants
- Where
- 13 sitesFrance
- Study dates
- 7 Oct 2015to 25 Jul 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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;
Show all 17Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
Centre Hospitalier d'Annecy
Annecy, 74011
Centre Catalan Urologie Andrologie
Cabestany, 66330
Centre hospitalier de Chambery
Chambéry, 73000
Hopital prive La Louviere
Lille, 59042
CHU de la Timone
Marseille, Cedex 5, 13335
Clinique Claude Bernard Chimiotherapie Ambulatoire
Metz, 57000
CRLC Val d'Aurelle
Montpellier, 34295
Polyclinique Gentilly
Nancy, 54000
Polyclinique de Gentilly Service Oncologie Médicale
Nancy, 54100
CHI de Cornouailles - Oncologie hospitalisation
Quimper, 29107
CHU Strasbourg
Strasbourg, Cedex, 67091
Hopital Jean BERNARD - Tours - 7eme etage
Valenciennes, 59300
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511
About this study
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
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).
Read the 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)..
- Conditions
- Metastatic/Advanced Renal Cell Carcinoma
- Being tested
- Best supportive care, call center
- Keywords
- sunitinib, call center, management of patients, nurses, metastatic renal carcinoma
- Medical subject headings
- Neoplasm Metastasis, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best supportive careOther
BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life
call centerOther
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 group | Role | What they receive |
|---|---|---|
| All patients | Metastatic and/or advanced renal cell carcinoma patients treated with sunitinib in first line and followed by standard care plus call center Receives: Other: Best supportive care; Other: call center |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: Baseline up to 6 months
Secondary outcomes (24)
Number of Participants With at Least 1 Sunitinib Dose Reduction
Number of participants treated with sunitinib having had at least 1 dose reduction relative to the initial dose are reported.
Measured: Baseline up to 6 months
Number of Participants Involved in at Least 1 Occasion For Each of the Reasons for a Sunitinib Dose Reduction
Number of participants treated with sunitinib having had at least 1 dose reduction relative to the initial dose according to the reasons for dose reductions are reported.
Measured: Baseline up to 6 months
Average Sunitinib Dose Reduction
Measured: Baseline up to 6 months
Number of Participants With at Least 1 Temporary Interruption of Sunitinib Treatment
Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor.
Measured: Baseline up to 6 months
Mean Duration (in Days) of Temporary Interruption to Sunitinib Treatment
Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor.
Measured: 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
Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor. Participants were counted in more than 1 category.
Measured: Baseline up to 6 months
Number of Participants Who Permanently Discontinued Sunitinib Treatment
Reason for permanent discontinuation of sunitinib treatment included: progressive disease, toxicity, participant's choice, doctor's choice and death of participant.
Measured: 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
Reason for permanent discontinuation of sunitinib treatment included: progressive disease, toxicity, participant's choice, doctor's choice and death of participant.
Measured: Baseline up to 6 months
Mean Duration of Sunitinib Treatment
Total mean duration (in months) of sunitinib treatment is reported in this outcome measure.
Measured: Baseline up to 6 months
Number of Participants Classified on the Basis of Number of Sunitinib Treatment Cycles
Last treatment cycle was declared by doctor either on the notified date to discontinue sunitinib or on the date of the last consultation if sunitinib treatment was not stopped
Measured: Baseline up to 6 months
Number of Participants With At Least 1 Unplanned Hospitalization
Number of participants with at least 1 unplanned hospitalizations either related or unrelated to sunitinib were reported.
Measured: Baseline up to 6 months
Number of Participants With At Least 1 Unplanned Consultation
Number of participants with at least 1 unplanned consultations either related or unrelated to sunitinib were reported.
Measured: Baseline up to 6 months
Number of Participants Who Were "Adherent" as Per 4- Item Morisky Medication Adherence Scale (MMAS-4)
MMAS-4 is a self-reported measure of medication taking behavior, consisting of 4 questions based on forgetting taking medication, carelessness about taking medication, stopping medication when feeling better, or stopping medication when feeling worse. Each question has answer either "Yes" or "No"; "Yes" =1 and "No" =0. The sum of answer to all 4 questions resulted in total MMAS-4 score. Total MMAS-4 score ranges from 0 (best adherence) to 4 (worst adherence), a low score representing improved adherence. Adherent participants were defined as participants with an MMAS-4 score of 0.
Measured: Baseline up to 6 months
Mean 4-Item Morisky Medication Adherence Scale (MMAS-4) Score
MMAS-4 is a self-reported measure of medication taking behavior, consisting of 4 questions based on forgetting taking medication, carelessness about taking medication, stopping medication when feeling better, or stopping medication when feeling worse. Each question has answer either "Yes" or "No"; "Yes" =1 and "No" =0. The sum of answer to all 4 questions resulted in total MMAS-4 score. Total MMAS-4 score ranges from 0 (best adherence) to 4 (worst adherence), a low score representing improved adherence. High adherence: score of 0, average adherence: score of 1 or 2, poor adherence: score of 3 or 4.
Measured: Baseline up to 6 months
Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Best Response
ORR used for the assessment of response to treatment. As per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: Complete response (CR) was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimetre [mm]). No new lesions. Partial response (PR) was defined as greater than or equal to (>=) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Measured: Baseline up to 6 months
Mean Scores for Each Dimension on the Participant's Satisfaction (With the Management By the Telephone Call Center) Questionnaire
Participants' satisfaction with call center was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 4 dimensions with total of 8 items. Dimensions were: 1) Satisfaction with advice: 3 item, 2) Satisfaction with care, 3) Satisfaction concerning the service: 3 items and 4) Overall satisfaction with support in management of sunitinib treatment: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion equivalent to score of +2, +1, 1, -2 and no score respectively. A score was calculated for each dimension by calculating the mean scores obtained for each item if at least 50% of the items for the dimension had been completed (and are not "no opinion"). Overall possible mean score range for each dimension was +2 to -2, where higher scores signified higher satisfaction.
Measured: 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
Participants' satisfaction with call center was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 4 dimensions with total of 8 items. Dimensions were: 1) Satisfaction concerning advice: have 3 item, 2) Satisfaction concerning management: 1 items, 3) Satisfaction concerning the service: 3 items and 4) Overall satisfaction with support in management of sunitinib treatment: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion. In this outcome measure number of participants who were either "Satisfied" or "Very Satisfied" for overall satisfaction were reported.
Measured: At the end of the study (At Month 6)
Mean Scores for Each Dimension on the Physician's Satisfaction (With the Management By the Telephone Call Center) Questionnaire
Physician's satisfaction with call center service for participants' follow-up was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 3 dimensions with total of 5 items. Dimensions were: 1) Satisfaction concerning advice: had 3 items, 2) Satisfaction concerning management: 1 items and 3) Overall satisfaction: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion equivalent to score of +2, +1, 1, -2 and no score respectively. A score was calculated for each dimension by calculating the mean scores obtained for each item if at least 50% of the items for the dimension have been completed (and are not "no opinion"). Overall possible mean score range for each dimension was +2 to -2, where higher scores signified higher satisfaction.
Measured: 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
Physicians' satisfaction with call center service for participants' follow-up was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 3 dimensions with total of 5 item. Dimensions were: 1) Satisfaction concerning advice: had 3 items, 2) Satisfaction concerning management: 1 items and 3) Overall satisfaction: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion. In this outcome measure number of physicians who were either "Satisfied" or "Very Satisfied" for overall satisfaction were reported.
Measured: Baseline up to 6 months
Total Number of Calls (Planned and Unplanned)
1 participant can call more than once during the study.
Measured: Baseline up to 6 months
Number of Participants Who Were Taking Sunitinib as Told to Call Center During the First Call
Participants were followed up for taking their medication and they were supposed to respond either "yes" or "no". In this outcome measure participants who responded "Yes" are reported.
Measured: First call made anytime from 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
Actions of investigating doctors/physicians: did doctor clearly explained how to take treatment, were participants given documentation about treatment by doctor or medical team, did doctor explained how to manage any side effects due to treatment which could occur and were prescriptions or orders for supportive medical treatments given by doctor. Participants responded either "Yes" or "No". In this outcome measure participants who responded "Yes" to each action are reported.
Measured: First call made anytime from baseline up to 6 months
Number of Telephone Calls Describing Actions Taken by Call Center
In this outcome measure number of telephone calls against each action taken/or described by the call center to the participants are reported. Actions taken by the call center included: 1) Given advice about managing the treatment: a) advice about taking Sunitinib, b) advice about using the Sunitinib follow-up diary, c) reporting any AE; 2) Given general preventative advice: a) advice about taking preventative systemic treatments, b) lifestyle advice, c) food/dietetic advice, d) oro-dental hygiene advice; 3) Given specific preventative advice for a type of AE: a) prevention of skin toxicities, b) prevention of gastrointestinal disorders, c) prevention of cardiac disorders, d) prevention of infectious/inflammatory problems, e)other preventative advice; 4) Actions recommended to participant: a) do not forget the planned consultation with the oncologist, b) get the additional investigations requested performed.
Measured: Baseline up to 6 months
Number of Telephone Calls Where Participants Declared Adverse Events
In this outcome measure total number of telephone calls where participants declared of any AE are reported. Participants could call more than once to declare AE.
Measured: Baseline up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study start7 Oct 2015
- Primary completion25 Jul 2018
- Study completion25 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic/Advanced Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187042
- Sponsor's protocol ID
- A6181213
- Other IDs
- RENACALL
- Acronym
- RENACALL
- Status last verified
- Oct 2019
- First submitted
- 8 Jul 2014
- Last updated
- 24 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: 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/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02187042
- Acronym / sponsor ID
- RENACALL / A6181213
- Conditions
- Metastatic/Advanced Renal Cell Carcinoma
- Keywords
- sunitinib, call center, management of patients, nurses, metastatic renal carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2015 (actual)
- Primary completion
- 25 Jul 2018 (actual)
- Study completion
- 25 Jul 2018 (actual)
- First posted
- 10 Jul 2014 (estimated)
- Results
- Posted 24 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Other: Best supportive care, Other: call centerMetastatic and/or advanced renal cell carcinoma patients treated with sunitinib in first line and followed by standard care plus call center |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (17 listed)
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best supportive careBSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life | Other | All patients |
| call centerNurses 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. | Other | All patients |
Primary outcome
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
Time frame: 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.
24 secondary outcomes
Number of Participants With at Least 1 Sunitinib Dose Reduction
Time frame: Baseline up to 6 months
Number of Participants Involved in at Least 1 Occasion For Each of the Reasons for a Sunitinib Dose Reduction
Time frame: Baseline up to 6 months
Average Sunitinib Dose Reduction
Time frame: Baseline up to 6 months
Number of Participants With at Least 1 Temporary Interruption of Sunitinib Treatment
Time frame: Baseline up to 6 months
Mean Duration (in Days) of Temporary Interruption to Sunitinib Treatment
Time frame: 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
Time frame: Baseline up to 6 months
Number of Participants Who Permanently Discontinued Sunitinib Treatment
Time frame: 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
Time frame: Baseline up to 6 months
Mean Duration of Sunitinib Treatment
Time frame: Baseline up to 6 months
Number of Participants Classified on the Basis of Number of Sunitinib Treatment Cycles
Time frame: Baseline up to 6 months
Number of Participants With At Least 1 Unplanned Hospitalization
Time frame: Baseline up to 6 months
Number of Participants With At Least 1 Unplanned Consultation
Time frame: Baseline up to 6 months
Number of Participants Who Were "Adherent" as Per 4- Item Morisky Medication Adherence Scale (MMAS-4)
Time frame: Baseline up to 6 months
Mean 4-Item Morisky Medication Adherence Scale (MMAS-4) Score
Time frame: Baseline up to 6 months
Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Best Response
Time frame: Baseline up to 6 months
Mean Scores for Each Dimension on the Participant's Satisfaction (With the Management By the Telephone Call Center) Questionnaire
Time frame: 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
Time frame: At the end of the study (At Month 6)
Mean Scores for Each Dimension on the Physician's Satisfaction (With the Management By the Telephone Call Center) Questionnaire
Time frame: 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
Time frame: Baseline up to 6 months
Total Number of Calls (Planned and Unplanned)
Time frame: Baseline up to 6 months
Number of Participants Who Were Taking Sunitinib as Told to Call Center During the First Call
Time frame: First call made anytime from 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
Time frame: First call made anytime from baseline up to 6 months
Number of Telephone Calls Describing Actions Taken by Call Center
Time frame: Baseline up to 6 months
Number of Telephone Calls Where Participants Declared Adverse Events
Time frame: Baseline up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic/Advanced Renal Cell Carcinoma, run by Pfizer at 13 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Baseline up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2019.