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NCT Number: NCT05444933

A Study to Collect Pre-existing Data on the Administration of Cabozantinib in Participants With Advanced Renal Cell Carcinoma (aRCC) Who Initiated Cabozantinib in 2nd Line in a Real-life Clinical Setting in France.

Cabozantinib is an orally bioavailable tyrosine kinase inhibitor (TKI) approved in patients with aRCC previously treated with a Vascular Endothelial Growth Factor (VEGF)-targeted therapy. Cabozantinib has been increasingly used in routine care in second line and more in advanced or metastatic RCC in France.

Cabozantinib effectiveness and safety notably in a real-word setting are now well known, but too many questions that arise during the routine care of patients with aRCC remain unanswered by the current literature.

Obtaining data on cabozantinib effectiveness and treatment pattern in those participants subpopulations will allow physicians to improve patients care.

The aims of this study are to describe the effectiveness - in terms of Duration of Treatment (DOT), Best Overall Response (BOR) and Progression-Free Survival (PFS) - and the safety of second line cabozantinib a real-life setting in France and to address the unanswered questions that arise during the routine care of patients with aRCC treated with cabozantinib in order to improve the care of these participants.

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Key information

Conditions

Advanced Renal Cell Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens, Amiens, France

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About this study

Since 2018, cabozantinib has been increasingly used in routine care in second line and more in advanced or metastatic RCC in France.

Cabozantinib effectiveness and safety notably in a real-word setting are now well known, but too many questions that arise during the routine care of patients with aRCC remain unanswered by the current literature.

As an example, there is currently no real-world data on cabozantinib in elderly patients (≥ 75 years old); in patients with a systemic therapy after progression under cabozantinib (only one published monocentric retrospective study on 56 participants); or in long responder patients (with a disease controlled after > 12 months of cabozantinib). Obtaining data on cabozantinib effectiveness and treatment pattern in those patient subpopulations will allow physicians to improve patients care.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female ≥ 18 age at the time of cabozantinib initiation.
  • Pathologically confirmed diagnosis of Renal Cell Carcinoma (RCC) considered as advanced at the time of cabozantinib initiation.
  • Cabozantinib initiated from 1st March 2018 to 1st March 2021 for an advanced RCC.
  • Cabozantinib initiated in 2nd line according to local Summary of Product Characteristics (SmPC).

Exclusion criteria

  • Participant medical file without documented follow-up visits (post-cabozantinib initiation).
  • Participant alive at study initiation who is opposed to data collection.
  • Participant who died before study initiation and who was opposed to data collection for research purposes when alive.

Treatment and study plan

Primary outcomes

  1. Duration of treatment (DOT) of cabozantinib

    Time frame: From baseline up to 18 months

    Defined as the time between first and last intake of cabozantinib treatment, regardless of the treatment discontinuation reason.

Secondary outcomes

  1. Best Overall Response (BOR), until disease progression/recurrence

    Time frame: From baseline up to 18 months

    Defined as the proportion of participants achieving the best response among Complete Response (CR), Partial Response (PR), Stable Disease (SDi) or Disease Progression (DP), The method used for the assessment of response to treatment will be left at the discretion of the physician

  2. Progression Free Survival (PFS).

    Time frame: From baseline up to 18 months

    Defined as the time from the date of first cabozantinib intake to the date of first documented progression reported by the investigator or death from any cause. Disease progression will be assessed by tumour response evaluation according to investigator assessment.

  3. Incidence of all adverse events (AEs).

    Time frame: From baseline up to 30 days after cabozantinib last intake

    Whether they are serious/non-serious, related/unrelated experienced by the participants during cabozantinib treatment period(s).

  4. Incidence of all Special Situations.

    Time frame: From baseline up to 30 days after cabozantinib last intake

    Whether they are serious/non-serious, related/unrelated experienced by the participants

  5. Type of subsequent therapy

    Time frame: From baseline up to 18 months

    Will be described in terms of type, other TKI, Immuno-Oncology therapy (IO), mammalian Target Of Rapamycin (mTOR) inhibitors, other

  6. DOT of subsequent therapy

    Time frame: From baseline up to 18 months

  7. Starting dose of subsequent therapy

    Time frame: From baseline up to 18 months

  8. Reasons for cabozantinib discontinuation

    Time frame: From baseline up to 18 months

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

OCTOPUS: An Observational, Non-interventional, Non-comparative, Retrospective, Multicentre Study in Patients With Advanced Renal Cell Carcinoma (aRCC) Who Initiated Cabozantinib in 2nd Line Under Real-life Setting in France.

Acronym: OCTOPUS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 6, 2022
Registry last updated
Jul 18, 2023

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.

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