Brain MetastasisNCT02913534
Hypofractionated Stereotactic Radiation Therapy of Brain Metastases: Evaluation of Whole-brain Radiotherapy
An observational study of Brain Metastasis, run by Institut de Cancérologie de Lorraine at 1 site in France.
Trial summary
The aim is to identify in patients with brain metastases the predictive factors of overall survival, survival without local recurrence and survival with progression-free brain metastases after complementary whole brain radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastasis
- What is being tested?
- whole brain radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2014to Jun 2014
- 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: Patients records would be extracted from the electronic health record system of Institut de Cancérologie de Lorraine.
Who may be able to join
- Patients with one to three brain metastases treated in our department with hypofractionated stereotactic radiotherapy (SRT) from March 2008 to February 2013.
Who cannot join
- A patient record captured after February 2013.
Trial locations and contacts
1 site in 1 country.
About this study
The aim is to identify in patients with brain metastases the predictive factors of overall survival, survival without local recurrence and survival with progression-free brain metastases after complementary whole brain radiotherapy.
- Conditions
- Brain Metastasis
- Being tested
- whole brain radiotherapy
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole brain radiotherapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startMar 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasisStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PHILIPPE ROYER, MD, Principal investigator, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913534
- Sponsor's protocol ID
- ICL_2014_0001
- Status last verified
- Sep 2016
- First submitted
- 22 Sep 2016
- Last updated
- 23 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated Stereotactic Radiation Therapy of Brain Metastases: Evaluation of Whole-brain Radiotherapy
- ClinicalTrials.gov ID
- NCT02913534
- Acronym / sponsor ID
- ICL_2014_0001
- Conditions
- Brain Metastasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 23 Sep 2016 (estimated)
- 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.
The aim is to identify in patients with brain metastases the predictive factors of overall survival, survival without local recurrence and survival with progression-free brain metastases after complementary whole brain radiotherapy.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients records would be extracted from the electronic health record system of Institut de Cancérologie de Lorraine.
Key inclusion criteria (1 listed)
- Patients with one to three brain metastases treated in our department with hypofractionated stereotactic radiotherapy (SRT) from March 2008 to February 2013.
Key exclusion criteria (1 listed)
- A patient record captured after February 2013.
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 |
|---|---|---|
| whole brain radiotherapy | Radiation | – |
Primary outcome
Overall survival
Time frame: 72 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
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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.
PHILIPPE ROYER, MD principal investigator
Institut de Cancérologie de Lorraine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Metastasis, run by Institut de Cancérologie de Lorraine at 1 site 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 1 inclusion and 1 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 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Overall survival (time frame: 72 months). 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 23 Sep 2016.