Study On Fatigue- And Hand-Foot Syndrome-Related Quality Of Life In Patients With Metastatic Renal Cell Carcinoma Receiving A Tyrosine Kinase Inhibitor as First-Line Treatment

NCT02789137

Last updated date
Study Location
Hospital Arquitecto Marcide de Ferrol
Ferrol, A Coruña, 15405, Spain
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients ≥ 18 years old and diagnosed with metastatic RCC who, in the investigator's opinion, are candidates for starting first-line treatment with a tyrosine kinase inhibitor according to routine clinical practice.

- Patients who have no contraindications to the treatment.

- Baseline ECOG ≤ 2.

- Patients who are able to give informed consent on their own without the need for a legal representative.

- Committed patients who are able to complete the quality of life questionnaires and patient diary on their own without the need for a legal representative.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Patients who are not candidates for first-line treatment with a tyrosine kinase
inhibitor.


- Patients who are receiving the treatment as second-line or subsequent therapy.


- Untreated hypothyroidism.


- Untreated severe anaemia.


- Pregnancy or breast-feeding.


- Myocardial infarction or cerebrovascular accidents (CVA) within the last 6 months.


- Severe hepatic impairment.


- Concomitant use of potent inhibitors or inducers that interact with hepatic cytochrome
CYP3A4.

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Advanced Information
Descriptive Information
Brief Title Study On Fatigue- And Hand-Foot Syndrome-Related Quality Of Life In Patients With Metastatic Renal Cell Carcinoma Receiving A Tyrosine Kinase Inhibitor as First-Line Treatment
Official Title PROSPECTIVE, MULTICENTRE, OBSERVATIONAL STUDY ON FATIGUE- AND HAND-FOOT SYNDROME-RELATED QUALITY OF LIFE IN PATIENTS WITH METASTATIC RENAL CELL CARCINOMA RECEIVING A TYROSINE KINASE INHIBITOR AS FIRST-LINE TREATMENT (TROYA STUDY).
Brief Summary The purpose of this study is to know about the quality of life of patients with metastatic renal cell carcinoma who are being treated with sunitinib, pazopanib or sorafenib, and who suffer from fatigue and hand-foot syndrome, with personal inter-variability, and to explore measures that can be taken in terms of both everyday lifestyle and treatment to mitigate or cure such side effects that affect patients.
Detailed Description

Prospective, multicentre, observational study in patients with metastatic renal cell carcinoma (mRCC) receiving a tyrosine kinase inhibitor as first-line treatment according to routine clinical practice, designed to evaluate the incidence of fatigue and hand-foot syndrome in order to determine how these affect the baseline characteristics of the patient and his/her disease (age, gender, baseline status, tumour histology, etc.) and the patient's lifestyle as such side effects develop.

An exploratory analysis will be performed of measures that clinicians may adopt to improve patients' quality of life with regards to daytime naps, medication administration time, off-treatment periods, dose reductions and treatment breaks.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 9 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population A population of 100 patients aged 18 years or over and diagnosed with metastatic renal cell carcinoma who are to start first-line treatment with a tyrosine kinase inhibitor according to routine clinical practice is to be studied
Condition Metastatic Renal Cell Carcinoma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: July 8, 2019)
111
Original Estimated Enrollment
 (submitted: May 27, 2016)
100
Estimated Study Completion Date September 30, 2020
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients ? 18 years old and diagnosed with metastatic RCC who, in the investigator's opinion, are candidates for starting first-line treatment with a tyrosine kinase inhibitor according to routine clinical practice.
  • Patients who have no contraindications to the treatment.
  • Baseline ECOG ? 2.
  • Patients who are able to give informed consent on their own without the need for a legal representative.
  • Committed patients who are able to complete the quality of life questionnaires and patient diary on their own without the need for a legal representative.

Exclusion Criteria:

  • Patients who are not candidates for first-line treatment with a tyrosine kinase inhibitor.
  • Patients who are receiving the treatment as second-line or subsequent therapy.
  • Untreated hypothyroidism.
  • Untreated severe anaemia.
  • Pregnancy or breast-feeding.
  • Myocardial infarction or cerebrovascular accidents (CVA) within the last 6 months.
  • Severe hepatic impairment.
  • Concomitant use of potent inhibitors or inducers that interact with hepatic cytochrome CYP3A4.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT02789137
Other Study ID Numbers A6181218
TROYA ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description: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/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators TFS Trial Form Support
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2020