Metastatic Renal CancerTOPTACOSNCT03630692
Safety and Compliance of Renal Cancer Patients Treated by Non-IV Drugs
An observational study of Metastatic Renal Cancer and Stage III Renal Cell Cancer, run by Institut Cancerologie de l'Ouest at 14 sites in France.
Trial summary
Generally, in the trials, an observant patient is described as correctly taking 90 to 100% of the prescribed doses. Here, the 80% compliance rate will be the cut-off between observant and non-observant patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cancer, Stage III Renal Cell Cancer
- What is being tested?
- observance of oral drug treatment
- Type of treatment
- Pill or oral medicine
- How many people
- 158 participants
- Where
- 14 sitesFrance
- Study dates
- 25 Mar 2016to Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Adult patients treated for a metastatic renal cancer by an oral route drug (sunitinib, axitinib, sorafenib, pazopanib, everolimus et cabozantinib) in Bretagne and Pays de la Loire area
Who may be able to join
- Adult patient
- Patient with metastatic or locally advanced kidney cancer
- Patient initiating for the first time an oral route anticancer drug : Sutent® (sunitinib), Nexavar® (sorafenib), Afinitor® (everolimus), Votrient® (pazopanib) and Inlyta® (axitinib) and Cabometyx® (cabozantinib)
- Patient having signed an informed consent
- Patient treated outside interventional clinical trial
Who cannot join
- Patient with cancer other than kidney cancer
- Patient with non-extensive kidney cancer
- Patient treated by surgery, radiotherapy and intravenous chemotherapy exclusively
- Patient unable to undergo protocol monitoring
- Patient included in an interventional trial
- Patient refusing a survey at home or having hearing problems
Show all 10Show fewer
- Other medical conditions that may interfere with the understanding of the informed consent document, with the assessment of tolerance and the response to questionnaires
- Patient with another condition deemed incompatible with the patient's inclusion into the protocol.
- Patient under guardianship or trusteeship, deprived of liberty, underage patient or pregnant woman
- Patient not affiliated with a social security system beneficiary of such a scheme
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites, 14 recruiting
- Recruiting
Institut de Cancérologie de l'Ouest
Angers, 49000
Abadie-Lacourtoisie Sophie, MD
- Recruiting
CHU
Angers, 49933
Bigot Pierre, MD
- Recruiting
Clinique Pasteur Saint Esprit
Brest, 29000
Hasbini Ali, MD
- Recruiting
CHU Morvan
Brest, 29609
Schlürmann Friedricke, MD
- Recruiting
CHD Vendée
La Roche-sur-Yon, 85925
L'Haridon Tifenn, MD
- Recruiting
Centre Hospitalier
Le Mans, 72000
Cojocarasu Oana, MD
- Recruiting
Clinique Victor Hugo
Le Mans, 72000
Voog Eric, MD
- Recruiting
Centre Catherine de Sienne
Nantes, 44000
El Kouri Claude, MD
- Recruiting
CHIC Quimper
Quimper, 29107
Schlürmann Friedricke, MD
- Recruiting
Centre Eugène Marquis
Rennes, 35042
Laguerre Brigitte, MD
- Recruiting
CHP
Saint-Grégoire, 35768
Artignan Xavier, MD
- Recruiting
Clinique Mutualiste de l'Estuaire
Saint-Nazaire, 44606
Deguiral Philippe, MD
- Recruiting
Centre Hospitalier
St-Malo, 35403
Desclos herve, MD
- Recruiting
CHP Océane
Vannes, 56000
Monpetit Erik, MD
About this study
Official title: Safety and Compliance of Patients Treated With Oral Route Anti Cancer Drugs.
Generally, in the trials, an observant patient is described as correctly taking 90 to 100% of the prescribed doses. Here, the 80% compliance rate will be the cut-off between observant and non-observant patients.
The evaluation methodology is based primarily on a survey of patients with metastatic or locally advanced kidney cancer who have just began an oral treatment protocol. The constitution of this cohort will be made from newly treated patients included by oncologists. The survey consists of implementing a series of questionnaires with each patient of the sample throughout the course of oral cancer care.
Read more
This series of questionnaires will aim to identify:
- the gradient of compliance of the patient with his treatment,
- all the factors likely to influence positively or negatively the latter, whether medical, material or socio-economic,
- the evolution of patient compliance during their treatment course,
- a patient's quality of life index through the standardized quality of life survey form (EORTC - Quality of Life Questionnaire QLQ C30 version 3).
- These questionnaires will be supplemented by the medical record data (including information on tolerance and possible drug interactions). The representativeness of the patients surveyed will be established by comparing the statistical characteristics of the surveyed population with those of the aggregate anonymous global data obtained by the two Medical Department of the French Regional Health Insurance of the two regions. From the data compiled by this study, different econometric models of patient behavior will seek to establish, in particular, a relationship between the probability that a given patient will be either non or poorly observant and the various variables proved to be statistically significant.
Read the detailed description
Data obtained from patients via the questionnaires will be copied into a computer database and as follows :
- The date of birth (day, month and year),
- Sex,
- The patient's opinion and attitude towards the current treatment: compliance, adverse effects, lifestyle restrictions, changes in professional activity, family activities, relationships, physical fitness, moral, concomitant treatments, expenses not refunded parallels related to the management of adverse effects,
- The family situation, the number of children,
- Degrees obtained and employment,
- Net monthly income.
In parallel with the questionnaires, the Clinical Research Associate (CRAs) of the Observatory will collect data from the medical file on site. The data collected on an electronic Case Report Form (e-CRF) are as follows:
- Type of cancer, date of diagnosis and metastatic disease, possible surgery and radiotherapy,
- Description of the different treatment lines: number of cures, start and end date, response, toxicities,
- Status of the patient at the end of the study.
The number of subjects needed is calculated from observant patients. Based on the existing literature on adherence to chemotherapy or targeted oral therapy, the observed compliance rate is approximately 80%. However, since this characteristic is the object of this study and therefore not known ex ante, in the calculations of the sample size, the value allowing to obtain the lowest margin of error on the rate of compliance, an estimated prevalence of 50% compliance is used. By setting the risk of the first species at 5%, a confidence level of 95%, it is then necessary to include 132 patients.
In addition, given the difficulty inherent in the questionnaires in collecting all the information, 20% of the data was estimated not to be evaluable. It will therefore be necessary to include 158 patients in the study to reach our goal.
- Being tested
- observance of oral drug treatment
- Keywords
- kidney cancer,, oral drug, safety, adherence
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observance of oral drug treatmentDrug
Also called oral drug treatment
Completion of questionnaires at 4 times during patient's oral route drug treatment
| Study group | Role | What they receive |
|---|---|---|
| observance of oral drug treatment | Study of observant or nonobservant patient behavior for their oral drug treatment Receives: Drug: observance of oral drug treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of observant or nonobservant patient behavior via patient questionnaire
Observance is first calculated via the use of the Morisky's score. The value of the score is between 0 and 4. The 0 corresponds to the absence of observance, the 4 to the perfect observance.
This score is completed by a question about drug delay (which measures poor compliance).
A subjective measure of compliance is also obtained from the patient's positioning of his compliance on a scale from 0 to 10. The value 0 corresponds to the fact that the person indicates that they do not comply at all with the treatment prescribed by the oncologist. Conversely, the value 10 corresponds to the exact respect of the treatment prescribed by the oncologist.
These two indicators are measured at different periods of treatment (1 month, 4 months ; 7 months and 10 months) via a patient questionnaire.
Measured: 11 months
Secondary outcomes (3)
Oral route Progression Free Survival evaluation (PFS)
PFS (duration between treatment start and progression date) will be evaluated via medical records analysis.
Measured: 11 months
Oral route Response rate analysis
Response rate will be evaluated via medical records analysis.
Measured: 11 months
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability).
adverse event due to treatment
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start25 Mar 2016
- Primary completionJan 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal CancerStudies of the same condition, open and under way.
- 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
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Collaborators
- Angers University, Fondation ARC
- Responsible party
- Sponsor
- Investigators
- Francoise GRUDE, Pharmacist, Principal investigator, Institut de Cancérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630692
- Sponsor's protocol ID
- TOPTACOS
- Acronym
- TOPTACOS
- Status last verified
- Aug 2018
- First submitted
- 6 Aug 2018
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Compliance of Patients Treated With Oral Route Anti Cancer Drugs.
- ClinicalTrials.gov ID
- NCT03630692
- Acronym / sponsor ID
- TOPTACOS / TOPTACOS
- Keywords
- kidney cancer,, oral drug, safety, adherence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Collaborators
- Angers University, Fondation ARC
- Study start
- 25 Mar 2016 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Generally, in the trials, an observant patient is described as correctly taking 90 to 100% of the prescribed doses. Here, the 80% compliance rate will be the cut-off between observant and non-observant patients.
The evaluation methodology is based primarily on a survey of patients with metastatic or locally advanced kidney cancer who have just began an oral treatment protocol. The constitution of this cohort will be made from newly treated patients included by oncologists. The survey consists of implementing a series of questionnaires with each patient of the sample throughout the course of oral cancer care.
This series of questionnaires will aim to identify:
- the gradient of compliance of the patient with his treatment,
- all the factors likely to influence positively or negatively the latter, whether medical, material or socio-economic,
- the evolution of patient compliance during their treatment course,
- a patient's quality of life index through the standardized quality of life survey form (EORTC - Quality of Life Questionnaire QLQ C30 version 3).
- These questionnaires will be supplemented by the medical record data (including information on tolerance and possible drug interactions). The representativeness of the patients surveyed will be established by comparing the statistical characteristics of the surveyed population with those of the aggregate anonymous global data obtained by the two Medical Department of the French Regional Health Insurance of the two regions. From the data compiled by this study, different econometric models of patient behavior will seek to establish, in particular, a relationship between the probability that a given patient will be either non or poorly observant and the various variables proved to be statistically significant.
Detailed description
Data obtained from patients via the questionnaires will be copied into a computer database and as follows :
- The date of birth (day, month and year),
- Sex,
- The patient's opinion and attitude towards the current treatment: compliance, adverse effects, lifestyle restrictions, changes in professional activity, family activities, relationships, physical fitness, moral, concomitant treatments, expenses not refunded parallels related to the management of adverse effects,
- The family situation, the number of children,
- Degrees obtained and employment,
- Net monthly income.
In parallel with the questionnaires, the Clinical Research Associate (CRAs) of the Observatory will collect data from the medical file on site. The data collected on an electronic Case Report Form (e-CRF) are as follows:
- Type of cancer, date of diagnosis and metastatic disease, possible surgery and radiotherapy,
- Description of the different treatment lines: number of cures, start and end date, response, toxicities,
- Status of the patient at the end of the study.
The number of subjects needed is calculated from observant patients. Based on the existing literature on adherence to chemotherapy or targeted oral therapy, the observed compliance rate is approximately 80%. However, since this characteristic is the object of this study and therefore not known ex ante, in the calculations of the sample size, the value allowing to obtain the lowest margin of error on the rate of compliance, an estimated prevalence of 50% compliance is used. By setting the risk of the first species at 5%, a confidence level of 95%, it is then necessary to include 132 patients.
In addition, given the difficulty inherent in the questionnaires in collecting all the information, 20% of the data was estimated not to be evaluable. It will therefore be necessary to include 158 patients in the study to reach our goal.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observance of oral drug treatment | – | Drug: observance of oral drug treatmentStudy of observant or nonobservant patient behavior for their oral drug treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients treated for a metastatic renal cancer by an oral route drug (sunitinib, axitinib, sorafenib, pazopanib, everolimus et cabozantinib) in Bretagne and Pays de la Loire area
Key inclusion criteria (5 listed)
- Adult patient
- Patient with metastatic or locally advanced kidney cancer
- Patient initiating for the first time an oral route anticancer drug : Sutent® (sunitinib), Nexavar® (sorafenib), Afinitor® (everolimus), Votrient® (pazopanib) and Inlyta® (axitinib) and Cabometyx® (cabozantinib)
- Patient having signed an informed consent
- Patient treated outside interventional clinical trial
Key exclusion criteria (10 listed)
- Patient with cancer other than kidney cancer
- Patient with non-extensive kidney cancer
- Patient treated by surgery, radiotherapy and intravenous chemotherapy exclusively
- Patient unable to undergo protocol monitoring
- Patient included in an interventional trial
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 |
|---|---|---|
| observance of oral drug treatmentAlso: oral drug treatmentCompletion of questionnaires at 4 times during patient's oral route drug treatment | Drug | observance of oral drug treatment |
Primary outcome
Study of observant or nonobservant patient behavior via patient questionnaire
Time frame: 11 months
Observance is first calculated via the use of the Morisky's score. The value of the score is between 0 and 4. The 0 corresponds to the absence of observance, the 4 to the perfect observance. This score is completed by a question about drug delay (which measures poor compliance). A subjective measure of compliance is also obtained from the patient's positioning of his compliance on a scale from 0 to 10. The value 0 corresponds to the fact that the person indicates that they do not comply at all with the treatment prescribed by the oncologist. Conversely, the value 10 corresponds to the exact respect of the treatment prescribed by the oncologist. These two indicators are measured at different periods of treatment (1 month, 4 months ; 7 months and 10 months) via a patient questionnaire.
3 secondary outcomes
Oral route Progression Free Survival evaluation (PFS)
Time frame: 11 months
Oral route Response rate analysis
Time frame: 11 months
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability).
Time frame: 11 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
Related trials for Metastatic Renal Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1/2
Pazopanib Hydrochloride and Bevacizumab in Treating Patients With Previously Untreated Metastatic Kidney Cancer
Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer
RecruitingPhase 2
Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma
Metastatic Melanoma, Advanced Locoregional Melanoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
RecruitingPhase 1
Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma
Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma
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.
Francoise GRUDE, Pharmacist principal investigator
Institut de Cancérologie de l'Ouest
14 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 Renal Cancer and Stage III Renal Cell Cancer, run by Institut Cancerologie de l'Ouest at 14 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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francoise GRUDE, Pharmacist (33241352868, francoise.grude@ico.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of observant or nonobservant patient behavior via patient questionnaire (time frame: 11 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 15 Oct 2018.