Stereotactic Radiotherapy for Brain Metastases

NCT03286023 | Unknown DMC

• 1 other identifier: CYM6 Brain metastases CFB 1
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastasis Brain

Keywords

brain metastases; stereotactic radiation; cyberknife

Outcome Measures

Primary Outcomes (2)

• Evaluation of tumoral response

  Evaluation of response using Magnetic resonance imaging (Recist criteria)

  4 weeks after treatment

• Evaluation of tumoral response

  Evaluation of response using Magnetic resonance imaging (Recist criteria)

  8 weeks after treatment

Secondary Outcomes (1)

• Evaluation of toxicity

  1, 3, 6, 9, 12, 15 months after treatment

Study Arms (1)

Stereotactic radiation

Stereotactic radiation for brain metastases

Radiation: stereotactic radiotherapy

Interventions

stereotactic radiotherapy RADIATION

stereotactic radiotherapy for brain metastases

Stereotactic radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with brain metastases

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Francois Baclesse, Luxembourg: lead

Study Sites (1)

Centre Francois Baclesse

Esch-sur-Alzette, SUD, L-4240, Luxembourg

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: September 18, 2017
• Study Start: October 1, 2014
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2022
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

LU (1)