Clinical trial · Observational
Observational Study Evaluating The Efficacy And Effects On Quality Of Life Of Targeted Treatments Following TKIs In mRCC
OBSERVATIONAL STUDY EVALUATING THE EFFICACY OF TARGETED TREATMENTS FOLLOWING TYROSINE KINASE INHIBITORS IN METASTATIC RENAL CELL CARCINOMA PATIENTS AND EFFECTS ON QUALITY OF LIFE: A NATIONAL, MULTICENTER STUDY
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Metastatic renal cell carcinoma (mRCC) is the most common malignant tumour of the kidneys. Targeted therapies, which were recently introduced in the treatment of mRCC, have become the standard treatment in these patients. With improved survival rate and a tolerable side effect profile, Tyrosine Kinase Inhibitors (TKIs) have largely replaced conventional immunotherapies worldwide. In Turkey, due to reimbursement conditions, cytokine (interferon alpha) treatment is the standard treatment as first-line therapy. Therefore, the data on quality of life (QoL) from the pivotal studies with standard TKI treatment does not reflect the QoL status of patients treated with TKIs as second or third line treatment in Turkey. In this study, the clinical outcomes and the impact on quality of life of targeted treatments following TKIs will be explored. To our knowledge, since there is no similar reimbursement condition in the world placing IFN as the first line standard treatment, this will be the first study evaluating the QoL status with targeted therapies used as 3rd line treatment in mRCC patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Study cohort
- description
- Metastatic renal cell carcinoma patients under 3rd line targeted therapy following 1st line interferon alpha and 2nd line TKI. All patients will be ≥ 18 years old and have signed the informed consent document.
Primary outcomes (17)
- measure
- Progression Free Survival (PFS)
- timeFrame
- From the start of disease treatment until disease progression or death due to any cause (up to a maximum of 33 months)
- description
- PFS was defined as the time duration (in months) during and after the treatment of disease that a participant lived with the disease but it did not get worse or progressed. Progressive disease as per response evaluation criteria in solid tumors (RECIST) version 1.1 defined as at least a 20 percent (%) increase in the sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions or increase of at least 5 millimeter (mm) in addition to the relative increase of 20%.
- measure
- Percentage of Participants With Overall Objective Response
- timeFrame
- Baseline until the maximum of 33 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: * Histologically confirmed metastatic renal cell cancer patients who have already been using targeted therapies for up to 3 months as 3rd line treatment * Patients older than 18 years * Evidence of a personally signed and dated informed consent document indicating that the patient (or a legal representative) has been informed of all pertinent aspects of the study. Exclusion criteria: Patients meeting any of the following criteria will not be included in the study: * Patients with contraindications for the use of the study medications * Patients with (suspected) pregnancy or in lactation period * Patients who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or patients who are Pfizer employees directly involved in the conduct of the trial. * Participation in other studies involving investigational drug(s) (Phases 1-4) within 4 weeks before included in the current study.
References
Publications (0)
Data not yet available