Skip to main content
OpenTrials
Completed

NCT Number: NCT05745142

A Study to go Back Into Records and Observe How People With Metastatic Renal Cell Carcinoma (mRCC) Who Received a Medicine Called Sunitinib Responded to This Medicine.

The purpose of this study is to understand how patients with mRCC respond to the study medicine (called sunitinib) when they receive it as the first line of treatment after finding out the cause for the disease.

This study will look into how different and how well groups of people with high chances of developing the disease respond to the study medicine.

All data for this study will be anonymously extracted from data already entered in RCC Registry which is owned by Turkish Oncology Group Association (TOGD).

This study will pull out records from the Registry between 01-Mar-2019 and 30-Oct-2022 that belongs to people:

* who are Turkish citizens * who are older than 18 years * who were found out to have mRCC * who received sunitinib as the first line treatment after finding out the cause for the disease

This study will look at the responses, experiences and how long the patients use the study medicine sunitinib.

Completed

Looking for future studies?

Notify Me

Key information

About this study

This study is designed as a local, non-interventional, retrospective, registry-based study to observe treatment response in patients with metastatic Renal Cell Carcinoma with Sunitinib First-Line Therapy based on data extracted and analyzed from the RCC Registry.

The annual disease burden in contributing centers to RCC Registry is approximately 100 patient/center, the treatment of an average of 250 patients per year is continued in the centers. Therefore, it is estimated that information of approximately 400 eligible patients who were registered in RCC Registry from 2019 to 2022 will be included in the analysis.

RCC Registry will be used as the sole data source for this study. For this purpose, no Case Report Forms (CRFs) or Data Collection Tools (DCTs) will be utilized, but the RCC Registry database will be used directly. Eligible patients' data will be anonymized and extracted for analysis by the registry owner, for this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being a Turkish citizen.
  • Being older than 18 years-old.
  • Being clinically diagnosed with mRCC and treated.
  • Being treated with Sunitinib in first line

Exclusion criteria

  • Patients whose treatment was initiated but excluded from follow-up for any reason.

Treatment and study plan

Sunitinib

Drug

as provided in real world practice

Primary outcomes

  1. Objective Response Rate (ORR) According to Disease Risk Group in IMDC

    Time frame: From initiation of sunitinib treatment (retrospective data) till PR and CR or death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]

    ORR: percentage of participants with partial response (PR) and complete response (CR). As per response evaluation criteria in solid tumors (RECIST)1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis); PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters. IMDC assessed as favorable (0), intermediate (1-2) or poor (>=3) based on number of criteria present (KPS <80%; time from diagnosis to start of systemic therapy <1 year; corrected serum calcium [Ca]; neutrophils and platelets >ULN; hemoglobin [hg] <LLN).

  2. Response Rates According to Disease Risk Group in IMDC

    Time frame: From initiation of sunitinib treatment (retrospective data) till PR/ CR/ SD/ death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]

    RECIST1.1- CR: disappearance of all lesions & normalization of tumor marker level. Any pathological lymph nodes must have reduction in short axis to <10 mm. All lymph nodes must be non-pathological in size (<10 mm short axis); PR: at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters; progressive disease (PD): at least 20% increase in sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since treatment started, or appearance of 1 or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%; stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. IMDC: favorable (0), intermediate (1-2) or poor (>=3) based on number of criteria present (KPS <80%; time from diagnosis to start of systemic therapy <1 year; corrected serum Ca]; neutrophils & platelets >ULN; hg <LLN).

  3. ORR According to Disease Risk Group in MSKCC

    Time frame: From initiation of sunitinib treatment (retrospective data) till PR and CR or death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]

    ORR: percentage of participants with PR and CR. As per RECIST 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis); PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters. MSKCC assessed as favorable (0), intermediate (1-2) or poor (>=3) based on number of criteria present [KPS <80%, time from diagnosis to start of systemic therapy <12 months, lactate dehydrogenase >1.5*ULN, hemoglobin <LLN, serum calcium >10 mg/dL].

  4. Response Rates According to Disease Risk Group in MSKCC

    Time frame: From initiation of sunitinib treatment (retrospective data) till PR/ CR/ SD/ death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]

    RECIST1.1- CR: disappearance of all lesions and normalization of tumor marker level. Any pathological lymph nodes must have reduction in short axis to <10 mm. All lymph nodes must be non-pathological in size (<10 mm short axis); PR: at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters; PD: at least 20% increase in sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since treatment started, or the appearance of 1 or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%; SD: neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. MSKCC assessed as favourable (0), intermediate (1-2) or poor (>=3) based on number of criteria present [KPS <80%, time from diagnosis to start of systemic therapy <12 months, lactate dehydrogenase >1.5*ULN, hemoglobin <LLN, serum calcium >10 mg/dL].

Secondary outcomes

  1. Overall Survival (OS) Rate According to Disease Risk Group in IMDC

    Time frame: From initiation of sunitinib treatment (retrospective data) till death or censored date (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]

    OS was defined as the time from the start of the treatment until the date of death. If no death was recorded, data was censored at latest available date in data. IMDC assessed as favorable (0), intermediate (1-2) or poor (>=3) based on number of criteria present (KPS <80%; time from diagnosis to start of systemic therapy <1 year; corrected serum Ca; neutrophils and platelets >ULN; hg <LLN).

  2. Progression-Free Survival (PFS) According to Disease Risk Group in IMDC

    Time frame: From initiation of sunitinib treatment (retrospective data) till progression end of treatment date or date of death (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]

    PFS: duration from start of treatment to disease progression (PD), end of treatment date or date of death. PD: at least 20% increase in sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since treatment started, or the appearance of 1 or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%. IMDC assessed as favorable (0), intermediate (1-2) or poor (>=3) based on number of criteria present (KPS <80%; time from diagnosis to start of systemic therapy <1 year; corrected serum Ca; neutrophils and platelets >ULN; hg <LLN).

  3. OS According to Disease Risk Group in MSKCC

    Time frame: From initiation of sunitinib treatment (retrospective data) till death or censored date (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]

    OS was defined as the time from the start of the treatment until the date of death. If no death was recorded, data was censored at latest available date in data. MSKCC assessed as favourable (0), intermediate (1-2) or poor (>=3) based on number of criteria present [KPS <80%, time from diagnosis to start of systemic therapy <12 months, lactate dehydrogenase >1.5*ULN, hemoglobin <LLN, serum calcium >10 mg/dL].

  4. PFS According to Disease Risk Group in MSKCC

    Time frame: From initiation of sunitinib treatment (retrospective data) till progression end of treatment date or date of death (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]

    PFS: duration from start of treatment to PD, end of treatment date or date of death. PD: at least 20% increase in sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since treatment started, or the appearance of 1 or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%. MSKCC assessed as favourable (0), intermediate (1-2) or poor (>=3) based on number of criteria present [KPS <80%, time from diagnosis to start of systemic therapy <12 months, lactate dehydrogenase >1.5*ULN, hemoglobin <LLN, serum calcium >10 mg/dL].

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Retrospective Registry Based Study for Evaluating Treatment Response in Patients Targeted Treated With Metastatic Renal Cell Carcinoma (mRCC) With Sunitinib in First-line Therapy

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 27, 2023
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.