AzTrials
AzTrials

Advanced Renal Cell CarcinomaOCTOPUSNCT05444933

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.

An observational study of Advanced Renal Cell Carcinoma, run by Ipsen at 28 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Renal Cell Carcinoma
How many people
252 participants
Where
28 sitesFrance
Study dates
16 Sep 2022to 12 May 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: An estimated total of 300 participants with aRCC and who started cabozantinib in 2nd line between 1st March 2018 and 1st March 2021 is planned to be included. Participants will be enrolled from approximately 25 centers in France

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

France28 sites

  • CHU Amiens

    Amiens

  • CHU Angers

    Angers

  • Institut Sainte Catherine

    Avignon

  • CHU Besançon

    Besançon

  • CHU Bordeaux

    Bordeaux

  • CHRU Brest

    Brest

  • Centre Chirurgie Urinaire et d'Andrologie

    Cabestany

  • CHU Clermont-Ferrand

    Clermont-Ferrand

  • APHP (Créteil)

    Créteil

  • Centre Hospitalier Annecy-Genevois

    Épagny

  • CHU Grenoble

    Grenoble

  • CHU Lille

    Lille

  • CHU Limoges

    Limoges

  • Centre Léon Bérard

    Lyon

  • Hôpital Edouard Herriot

    Lyon

  • Polyclinique de Gentilly

    Nancy

  • CHU Nice

    Nice

  • APHP

    Paris, 75013

  • APHP

    Paris, 75014

  • APHP (Paris Grenelle)

    Paris, 75015

  • Institut Mutualiste Montsouris

    Paris

  • Hospices civils de Lyon

    Pierre-Bénite

  • CH Quimper

    Quimper

  • CHU Reims

    Reims

  • Hôpital Foch

    Suresnes

  • Oncopole CHU Toulouse

    Toulouse

  • CHRU Tours

    Tours

  • Institut Gustave Roussy

    Villejuif

Other trials in France

About this study

Official 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.

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.

Read more

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.

Read the detailed description

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.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05444933
Study groupRoleWhat they receive
Sequencing post-cabozantinibParticipants treated by cabozantinib and who received another systemic therapy post-cabozantinib.
Long respondersParticipants treated by cabozantinib and who had a disease controlled (CR, PR or SDi during > 12 months after cabozantinib initiation with or without additional local treatment).
Non-respondersParticipants treated by cabozantinib and who had a progressive disease less than 3 months after cabozantinib treatment initiation.
Cabozantinib & rechallengeParticipants treated by cabozantinib who received systemic therapy and/or had prolonged treatment-free interval (≥ 12 weeks) between two cabozantinib treatment periods. Participants with at least one cabozantinib rechallenge could be included in this subgroup.
Cabozantinib & therapeutic schedulesParticipants treated by cabozantinib and who needed 1/ a dose increase following disease progression and/or a prior reduction, Or 2/ had any dose reduction/dose interruption of cabozantinib (schedule adaptation).
Cabozantinib & local treatmentParticipants treated by cabozantinib and who needed concomitant local treatment (LT) by surgery or radiotherapy
Cabozantinib & elderly patientsParticipants treated by cabozantinib and aged ≥ 75 years

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of treatment (DOT) of cabozantinib

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

    Measured: From baseline up to 18 months

Secondary outcomes (8)

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

    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

    Measured: From baseline up to 18 months

  2. Progression Free Survival (PFS).

    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.

    Measured: From baseline up to 18 months

  3. Incidence of all adverse events (AEs).

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

    Measured: From baseline up to 30 days after cabozantinib last intake

  4. Incidence of all Special Situations.

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

    Measured: From baseline up to 30 days after cabozantinib last intake

  5. Type of subsequent therapy

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

    Measured: From baseline up to 18 months

  6. DOT of subsequent therapy

    Measured: From baseline up to 18 months

  7. Starting dose of subsequent therapy

    Measured: From baseline up to 18 months

  8. Reasons for cabozantinib discontinuation

    Measured: From baseline up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2022
  2. Study start16 Sep 2022
  3. Primary completion12 May 2023
  4. Study completion12 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
252 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05444933
Sponsor's protocol ID
CLIN-60000-454
Acronym
OCTOPUS
Status last verified
Jul 2023
First submitted
30 Jun 2022
Last updated
18 Jul 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

Questions about this trial

What is this clinical trial studying?

An observational study of Advanced Renal Cell Carcinoma, run by Ipsen at 28 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of treatment (DOT) of cabozantinib (time frame: From baseline up to 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05444933.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in