NCT03286023UnknownNot Applicable
Stereotactic Radiotherapy for Patients With Brain Metastases
Centre Francois Baclesse, Luxembourg1 site in 1 country110 target enrollmentStarted: October 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Evaluation of tumoral response
Study Overview
Brief Summary
Stereotactic radiotherapy is an innovative treatment enabling to target accurately brain metastases. The aim of this study is to evaluate tumoral response and acute and late toxicity of this treatment.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Situation 1: in case of several cerebral metastases. In this case, the maximum of cerebral metastases is 3, and the maximum diameter of the largest can not exceed 3 cm. The other two ones can not exceed 1 cm or even maximum 2 cm in diameter for one of the two. The same principle will remain valid in the presence of 2 metastases.
- •Situation 2: in the case of a single metastasis, the diameter should be a maximum of 3 cm
- •Situation 3: in case of metastasis supposed to be radioresistant (renal adenocarcinoma, sarcoma, melanoma ...), only a single metastasis of not more than 3 cm in diameter will be accepted. A primary resection followed by radiotherapy will be preferred.
- •Situation 4: In case of localization near a structure at risk (contact with anterior optical pathways, central nuclei or the brainstem or localization in these structures), a maximum number of 3 metastases may be accepted. However, that included in or close to the risk structure can not exceed 2 cm in diameter and the other two, located outside a risk structure will have a diameter not exceeding 1 or even maximum 2 cm.
- •Situation 5: single metastasis of maximum 3 cm in a context of re-irradiation, the whole encephalon having already received the dose of 10 X 3 Gy or its biological equivalent of dose.
- •Signed informed consent
Exclusion Criteria
- •Impossibility of performing an MRI or a CT-scan of the brain with injection of contrast agent
- •Metastases greater than 3 cm at the start
Outcomes
Primary Outcomes
Evaluation of tumoral response
Time Frame: 8 weeks after treatment
Evaluation of response using Magnetic resonance imaging (Recist criteria)
Secondary Outcomes
- Evaluation of toxicity(1, 3, 6, 9, 12, 15 months after treatment)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Not Applicable
Stereotactic Radiotherapy in Oligometastatic Brain Disease: a Randomised Phase III Study Comparing Hypofractionated Stereotactic Radiation Therapy (3*10 Gy) to the Historical Single-dose Radiosurgery (1*20 to 25 Gy) With Medico-economic Evaluation.Brain MetastasisOligoprogressionNCT05102747Centre Francois Baclesse504
Completed
Phase 2
Stereotactic Radiotherapy of the Resection Cavity of Brain Metastases vs. Post-operative Whole-brain RadiotherapyBrain Metastases, AdultNCT03285932Juergen Debus56
Recruiting
Not Applicable
Stereotactic Radiotherapy Management of Brain Metastases: the Value of a Longitudinal Multimodal Approach (POSTPONE)Brain Metastases, AdultNCT06029140University Hospital, Brest700
Completed
Phase 2
Stereotactic Radiation Therapy in Treating Patients With Brain MetastasesMetastatic CancerNCT00006259Case Comprehensive Cancer Center10
Completed
Not Applicable
Cyberknife Radiosurgery for Patients With Brain Metastases Diagnosed With Either SPACE or MPRAGE SequenceBrain MetastasesAdult Solid TumorNCT03303365Juergen Debus203