GISTNCT04097093
Long-term Surival of GIST Patients ≥ 10 Years on Imatinib
An observational study of GIST, run by European Organisation for Research and Treatment of Cancer - EORTC.
Trial summary
This is a cross-sectional cohort study of metastatic GastroIntestinal Stromal Tumor (GIST) patients on imatinib for ≥ 10 years included in EORTC trial 62005-STBSG entitled "Phase 3 randomized, intergroup, international tiral assessing the clinical activity of STI-571 at two dose levels in patients with unresectable or… Read more about this study
- Who is it for?
- Ages 28 years and older
- Conditions the study is for
- GIST
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 1 Jun 2021
- How long will I take part?
- 1 Day
- 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 28 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients enrolled in the 62005 trial - treated for more than 10 years with imatinib - will be enrolled in this study.
Who may be able to join
- Patients included in the EORTC 62005 trial: Adult patients with metastasized GIST
- Patients who have been treated with imatinib for ten years or longer
- For the identified patients who are still alive:
- Able to read and answer questionnaires
- Able to provide written informed consent
Who cannot join
None listed.
About this study
Official title: Long-term Survival of Advanced/Metastatic GIST Patients Responding to Imatinib Treatment: an Observational Follow-up Study
This is a cross-sectional cohort study of metastatic GastroIntestinal Stromal Tumor (GIST) patients on imatinib for ≥ 10 years included in EORTC trial 62005-STBSG entitled "Phase 3 randomized, intergroup, international tiral assessing the clinical activity of STI-571 at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumor (GIST) expressing the KIT receptor tyrosine kinase (CD117) - NCT00685828". With this study, the aim is to identify patient characteristics, tumour characteristics, treatment factors and quality of life outcomes associated with prolonged treatment with imatinib and/or prolonged survival. This observational study will further help to put in place a questionnaire to evaluate patients quality of life with prolonged imatinib treatment, that will then be used in a prospective study.
- Conditions
- GIST
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Study 62005-STBSG patients treated with imatinib > 10 years | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient characteristics
Age at time of randomization, gender, medical history and previous treatment(s)
Measured: At time of registration
Tumour characteristics
Stage of the disease, tumor grade, tumor location and molecular features of primary tumor
Measured: At time of registration
Duration of imatinib treatment
Time on imatinib treatment from start untill definitive discontinuation of imatinib treatment
Measured: At time of registration
Health releated quality of life
QLQ-C30
Measured: At time of registration
Overall survival
From time of randomization to the date of death, whatever the cause
Measured: At time of registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start1 Jun 2020 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Jun 2021 (estimated)
Why it stopped: Lack of feasibility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GISTStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cross-sectional
- Enrolment
- 0 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Neeltje Steeghs, Study chair, NKI - Antoni van LeeuwenhoekziekenhuisAxel Le Cesne, Study chair, Gustave Roussy, Cancer Campus, Grand ParisIngrid Desar, Study chair, Radboud University Medical Center NijmegenOlga Husson, Study chair, Radboud University Medical Center Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097093
- Sponsor's protocol ID
- EORTC 1826-STBSG
- Status last verified
- Sep 2020
- First submitted
- 7 Aug 2019
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Survival of Advanced/Metastatic GIST Patients Responding to Imatinib Treatment: an Observational Follow-up Study
- ClinicalTrials.gov ID
- NCT04097093
- Acronym / sponsor ID
- EORTC 1826-STBSG
- Conditions
- GIST
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of feasibility
- Enrolment
- 0 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 20 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a cross-sectional cohort study of metastatic GastroIntestinal Stromal Tumor (GIST) patients on imatinib for ≥ 10 years included in EORTC trial 62005-STBSG entitled "Phase 3 randomized, intergroup, international tiral assessing the clinical activity of STI-571 at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumor (GIST) expressing the KIT receptor tyrosine kinase (CD117) - NCT00685828". With this study, the aim is to identify patient characteristics, tumour characteristics, treatment factors and quality of life outcomes associated with prolonged treatment with imatinib and/or prolonged survival. This observational study will further help to put in place a questionnaire to evaluate patients quality of life with prolonged imatinib treatment, that will then be used in a prospective study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study 62005-STBSG patients treated with imatinib > 10 years | – | Other: No intervention |
Who may qualify
- Ages
- 28 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients enrolled in the 62005 trial - treated for more than 10 years with imatinib - will be enrolled in this study.
Key inclusion criteria (5 listed)
- Patients included in the EORTC 62005 trial: Adult patients with metastasized GIST
- Patients who have been treated with imatinib for ten years or longer
- For the identified patients who are still alive:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Study 62005-STBSG patients treated with imatinib > 10 years |
Primary outcome
Patient characteristics
Time frame: At time of registration
Age at time of randomization, gender, medical history and previous treatment(s)
Tumour characteristics
Time frame: At time of registration
Stage of the disease, tumor grade, tumor location and molecular features of primary tumor
Duration of imatinib treatment
Time frame: At time of registration
Time on imatinib treatment from start untill definitive discontinuation of imatinib treatment
Health releated quality of life
Time frame: At time of registration
QLQ-C30
Overall survival
Time frame: At time of registration
From time of randomization to the date of death, whatever the cause
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neeltje Steeghs study chair
NKI - Antoni van Leeuwenhoekziekenhuis
Axel Le Cesne study chair
Gustave Roussy, Cancer Campus, Grand Paris
Ingrid Desar study chair
Radboud University Medical Center Nijmegen
Questions about this trial
What is this clinical trial studying?
An observational study of GIST, run by European Organisation for Research and Treatment of Cancer - EORTC.
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 5 inclusion and 0 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: withdrawn, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Patient characteristics (time frame: At time of registration). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2020.