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

Overview

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.

Full Title of Study: “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).”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 30, 2020

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.

Clinical Trial Outcome Measures

Primary Measures

  • Fatigue-related quality of life with validated 13-item FACIT-Fatigue scale for patients with metastatic renal cancer in Spanish
    • Time Frame: 9 months
    • Fatigue-related quality of life of patients receiving a tyrosine kinase inhibitor evaluated using the validated 13-item FACIT-Fatigue scale for patients with metastatic renal cancer in Spanish

Secondary Measures

  • Quality of life in patients with palmar-plantar erythrodysaesthesia according to version 4 of the CTCAE
    • Time Frame: 9 months
    • Quality of life in patients with palmar-plantar erythrodysaesthesia
  • Assessment of adverse effects according to version 4 of the CTCAE
    • Time Frame: 9 months
    • To assess the following adverse effects according to version 4 of the CTCAE (Common Terminology Criteria for Adverse Events): any grade of fatigue and hand-foot syndrome (HFS).
  • Time to Treatment Failure (TTF)
    • Time Frame: 9 months
    • Time to Treatment Failure (TTF), defined as the time from the start of treatment with a tyrosine kinase inhibitor to tumour progression, treatment discontinuation for any reason or death from any cause.
  • Progression-Free Survival (PFS) (median)
    • Time Frame: 9 months
    • Progression-Free Survival (PFS) (median): time from the start of treatment with a tyrosine kinase inhibitor to tumour progression or death from any cause.
  • Objective Response Rate according to RECIST version 1.1.
    • Time Frame: 9 months
    • Objective Response Rate according to RECIST version 1.1.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Collaborator
    • TFS Trial Form Support
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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