Brain MetastasisSBRTNCT02013297
Study of SBRT Efficacy on Intra and Extra -Cranial Tumors or Metastasis in Pediatrics Population (SBRT Pediatrics)
A study testing SBRT treatment in people with Brain Metastasis and Spinal Tumors, run by Centre Leon Berard at 15 sites in France.
Trial summary
The purpose of this study is to evaluate the efficacy of hypofractionated stereotactic radiation treatments (SBRT) on children, teenagers and young adults malignant tumors. Read more about this study
- Who is it for?
- Ages 18 months to 20 years
- Conditions the study is for
- Brain Metastasis, Spinal Tumors, Lung Tumors
- What is being tested?
- SBRT treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 15 sitesFrance
- Study dates
- 3 Dec 2013to 12 Oct 2021
- Phase
- Interventional
- 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 months to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 18 months ≤ age ≤ 20 years
- Malignant primary tumor, histologically or cytologically proven
- Systemic disease under control or with slow evolution
- Written indication of SBRT according to local pediatrics meeting and national Radiotherapy (RT) web conference
- Performance Status ≤ 2 according to Eastern Cooperative Oncology Group (ECOG)
- Sites
Show all 33Show fewer
- Brain metastasis (≤ 3 on MRI) not suitable for surgery, without hemorrhage, less than 3 cm each, not in the brain stem
- Primary or secondary spinal/para spinal metastasis (≤ 3), not suitable for surgery or with a non operable macroscopic residue, less than 5 cm
- Lung metastasis (≤ 3), less than 5 cm, not eligible for surgery, or macroscopic residue not suitable for surgery
- Previously irradiated relapsing isolated primitive/secondary tumor (intra cranial or extra cranial), with no possible surgery, or macroscopic residue.
- Affiliation to a social security scheme
- Signed Informed consent by patient or parents and patient
- IN ADDITION FOR RELAPSING EPENDYMOMA:
- Histologically proven local ependymoma at diagnosis
- Previously irradiated ependymoma
- Exclusive local relapse in previously irradiated site
- Review of operability at time of relapse by a multidisciplinary staff
- Relapse must be confirmed by a neuro-oncology multidisciplinary staff, on MRI evolutivity characteristics
- Time to relapse after previous irradiation ≥ 1 year
- NON-INCLUSION CRITERIA :
- Concomitant chemotherapy
- No evaluable target (except for completely resected ependymomas)
- Pregnancy
- Follow-up impossible
- IN ADDITION FOR RELAPSING EPENDYMOMAS:
- Metastatic patient at diagnosis and/or at relapse
- Complete remission never obtained
- NON-RANDOMIZATION DOSIMETRIC CRITERIA (ONLY FOR EPENDYMOMA)
- Cumulative doses to brain stem ≥ 115 Gy
- Tumor volume at relapse ≥ 30 cm3
- Primary RT dose + Re-irradiation dose more than 112 Gy
- Cumulative dose to the chiasma > 54 Gy
- Cumulative dose to any point of the brain > 115 Gy
Who cannot join
None listed.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
CHU Bordeaux - Hôpital Saint André
Bordeaux, Gironde, 33000
Centre François Baclesse
Caen, Calvados, 14000
Centre Oscar Lambret
Lille, Nord, 59020
Centre Léon Bérard
Lyon, Rhône, 69373
Hôpital La Timone
Marseille, Bouches Du Rhône, 13500
Institut de Cancérologie de Montpellier
Montpellier, Hérault, 34298
Centre Antoine Lacassagne
Nice, Alpes Maritimes, 06050
Institut Curie
Paris, Île-de-France Region, 75231
Centre Eugène Marquis
Rennes, Ille Et Vilaine, 35062
Institut de Cancérologie de l'Ouest René Gauducheau
Saint-Herblain, Loire Atlantique, 44805
Centre Paul Strauss
Strasbourg, Bas-Rhin, 67805
Centre Claudius Régaud
Toulouse, Haute Garonne, 31052
CHRU de Tours - Hôpital Bretonneau
Tours, Indre Et Loire, 37044
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, Meurthe Et Moselle, 54511
Institut Gustave Roussy
Villejuif, Val De Marne, 94805
About this study
Official title: Hypofractionated Stereotactic Radiation Treatments (SBRT) on Children, Teenagers and Young Adults Malignant Tumors
The purpose of this study is to evaluate the efficacy of hypofractionated stereotactic radiation treatments (SBRT) on children, teenagers and young adults malignant tumors.
Read the detailed description
SBRT (Stereotactic Body Radiation Therapy) is a radiotherapy treatment which involves the delivery of a single high dose radiation treatment or a few fractionated radiation treatments (usually up to 5). A high potent biological dose of radiation is delivered to the tumor improving the cure rates for the tumor, in a manner previously not achievable by standard conventional radiation therapy.
For adult patients, the "Haute Authorité de Santé" (HAS) validates some indications for this treatment which are the followings :
- Few primary or secondary brain tumors, which cannot be surgically removed
- Spinal tumors
- Primary bronchopulmonary tumors T1 T2 N0 M0 and pulmonary metastasis with slow growth and controled primary tumor.
For pediatrics patients, no indication is now validated by HAS. Indications validated for adults are rare in pediatrics but not exceptional, and in such cases efficient alternative treatments does not exist.
In consequence, and regarding the good results obtained in adult patients, it seems very important to validate the efficacy of this treatment on pediatrics population
- Conditions
- Brain Metastasis, Spinal Tumors, Lung Tumors, Ependymoma
- Being tested
- SBRT treatment
- Keywords
- Pediatrics, SBRT, Brain metastasis, Pulmonary metastasis, Spinal metastasis, Pulmonary primary tumor, Spinal primary tumor, Relapsed ependymoma, Relapsed irradiated tumors, Local control rate, Safety, Overall survival, Progression Free Survival
- Medical subject headings
- Brain Neoplasms, Spinal Cord Neoplasms, Lung Neoplasms, Ependymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRT treatmentRadiation
For Brain metastasis the SBRT treatment consists on 3 fractions of 8 Gy or 5 fractions of 7 Gy or 1 fraction of 18 Gy for a single metastasis which is less than 20 mm.
For primary or secondary pulmonary tumors the SBRT treatment consists on 3 fractions of 15 Gy or 5 fractions of 10 Gy for peripheral lesions and on 5 fractions of 8 Gy for proximal lesions.
For primary or secondary spinal or para-spinal tumors the SBRT treatment consists on 3 fractions of 9 Gy or 5 fractions of 7 Gy.
For previously irradiated tumors (same locations) the SBRT treatment consists on 5 to 8 fractions of 5 Gy.
For relapsed Ependymoma previously irradiated the SBRT treatment will be allocated by surgical stratified randomization and consists on either 3 fractions of 8 Gy or 5 fractions of 5 Gy.
| Study group | Role | What they receive |
|---|---|---|
| SBRT treatment | Experimental | According to the site to irradiate and to local constraints, SBRT consist in 1 to 8 fractions of 5 to 18 Gy Receives: Radiation: SBRT treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of SBRT assessed 6 months after treatment
The treatment efficacy is assessed by calculation of local control rate of irradiated locations according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria (complete response + partial response + stable disease)
Measured: 6 months after inclusion
Secondary outcomes (8)
Efficacy of SBRT assessed between 1,5 and 3 months after treatment
The treatment efficacy is assessed by calculation of local control rate of irradiated locations according to RECIST version 1.1 criteria (complete response + partial response + stable disease) between 1,5 and 3 months after treatment
Measured: Between 1,5 and 3 months after inclusion
Progressive Free Survival
Calculated from the date of inclusion to the date defined as the first documented disease progression, or second cancer appearance, or death from any cause (Up to 5 years since the first inclusion)
Measured: From the date of inclusion to the date of progression
Overall Survival
Calculated from the date of inclusion to the date of death from any cause (Up to 5 years since the first inclusion)
Measured: From the date of inclusion to the date of death (Up to 5 years since the first inclusion)
Short time Safety profile of SBRT
Toxicities appeared during SBRT treatment and up to 3 months after SBRT. Toxicities will be assessed by the evaluation of intensity and incidence of the Adverse Events (AE) displayed by patients. The intensity of each AE will be classified according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: From inclusion to 3 months after inclusion
Long term Safety profile of SBRT
Toxicities appeared after 24 months after inclusion. The outcome measure concerns toxicities appeared after the study following period. Toxicities will be assessed by the evaluation of intensity and incidence of the Adverse Events (AE) displayed by patients. The intensity of each AE will be classified according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: after 24 months after inclusion
Efficacy of SBRT assessed 12 months after treatment
The treatment efficacy is assessed by calculation of local control rate of irradiated locations according to RECIST version 1.1 criteria (complete response + partial response + stable disease) at 12 months after treatment
Measured: 12 months after inclusion
Efficacy of SBRT assessed 24 months after treatment
The treatment efficacy is assessed by calculation of local control rate of irradiated locations according to RECIST version 1.1 criteria (complete response + partial response + stable disease) at 24 months after treatment
Measured: 24 months after inclusion
Medium time Safety profile of SBRT
Toxicities appeared between 3 months and 24 months after treatment. Toxicities will be assessed by the evaluation of intensity and incidence of the Adverse Events (AE) displayed by patients. The intensity of each AE will be classified according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: Between 3 months and 24 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study start3 Dec 2013
- Primary completion3 Apr 2020
- Study completion12 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Brain MetastasisStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Line CLAUDE, Doctor, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013297
- Sponsor's protocol ID
- SBRT
- Acronym
- SBRT
- Status last verified
- Mar 2022
- First submitted
- 5 Dec 2013
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Timmerman RD. An overview of hypofractionation and introduction to this issue of seminars in radiation oncology. Semin Radiat Oncol. 2008 Oct;18(4):215-22. doi: 10.1016/j.semradonc.2008.04.001. No abstract available.
PubMed 18725106Rapport ANAES : Evaluation clinique et économique de la radiochirurgie intra cranienne en conditions stéréotaxique - Rapport ANAES/Service évaluation des technologies-évaluation économique: 2000.
Rapport HAS : Radiothérapie extra crânienne en conditions stéréotaxiques - Décembre 2006: 2006.
Maranzano E, Anselmo P, Casale M, Trippa F, Carletti S, Principi M, Loreti F, Italiani M, Caserta C, Giorgi C. Treatment of recurrent glioblastoma with stereotactic radiotherapy: long-term results of a mono-institutional trial. Tumori. 2011 Jan-Feb;97(1):56-61. doi: 10.1177/030089161109700111.
PubMed 21528665Minniti G, Armosini V, Salvati M, Lanzetta G, Caporello P, Mei M, Osti MF, Maurizi RE. Fractionated stereotactic reirradiation and concurrent temozolomide in patients with recurrent glioblastoma. J Neurooncol. 2011 Jul;103(3):683-91. doi: 10.1007/s11060-010-0446-8. Epub 2010 Nov 5.
PubMed 21052773Torok JA, Wegner RE, Mintz AH, Heron DE, Burton SA. Re-irradiation with radiosurgery for recurrent glioblastoma multiforme. Technol Cancer Res Treat. 2011 Jun;10(3):253-8. doi: 10.7785/tcrt.2012.500200.
PubMed 21517131Zacharoulis S, Ashley S, Moreno L, Gentet JC, Massimino M, Frappaz D. Treatment and outcome of children with relapsed ependymoma: a multi-institutional retrospective analysis. Childs Nerv Syst. 2010 Jul;26(7):905-11. doi: 10.1007/s00381-009-1067-4. Epub 2009 Dec 29.
PubMed 20039045Kano H, Yang HC, Kondziolka D, Niranjan A, Arai Y, Flickinger JC, Lunsford LD. Stereotactic radiosurgery for pediatric recurrent intracranial ependymomas. J Neurosurg Pediatr. 2010 Nov;6(5):417-23. doi: 10.3171/2010.8.PEDS10252.
PubMed 21039163Liu AK, Foreman NK, Gaspar LE, Trinidad E, Handler MH. Maximally safe resection followed by hypofractionated re-irradiation for locally recurrent ependymoma in children. Pediatr Blood Cancer. 2009 Jul;52(7):804-7. doi: 10.1002/pbc.21982.
PubMed 19260098Combs SE, Behnisch W, Kulozik AE, Huber PE, Debus J, Schulz-Ertner D. Intensity Modulated Radiotherapy (IMRT) and Fractionated Stereotactic Radiotherapy (FSRT) for children with head-and-neck-rhabdomyosarcoma. BMC Cancer. 2007 Sep 13;7:177. doi: 10.1186/1471-2407-7-177.
PubMed 17854490Giller CA, Berger BD, Pistenmaa DA, Sklar F, Weprin B, Shapiro K, Winick N, Mulne AF, Delp JL, Gilio JP, Gall KP, Dicke KA, Swift D, Sacco D, Harris-Henderson K, Bowers D. Robotically guided radiosurgery for children. Pediatr Blood Cancer. 2005 Sep;45(3):304-10. doi: 10.1002/pbc.20267.
PubMed 15558704Grabb PA, Lunsford LD, Albright AL, Kondziolka D, Flickinger JC. Stereotactic radiosurgery for glial neoplasms of childhood. Neurosurgery. 1996 Apr;38(4):696-701; discussion 701-2.
PubMed 8692387Hodgson DC, Goumnerova LC, Loeffler JS, Dutton S, Black PM, Alexander E 3rd, Xu R, Kooy H, Silver B, Tarbell NJ. Radiosurgery in the management of pediatric brain tumors. Int J Radiat Oncol Biol Phys. 2001 Jul 15;50(4):929-35. doi: 10.1016/s0360-3016(01)01518-8.
PubMed 11429220Chawla S, Schell MC, Milano MT. Stereotactic body radiation for the spine: a review. Am J Clin Oncol. 2013 Dec;36(6):630-6. doi: 10.1097/COC.0b013e31822dfd71.
PubMed 22134513Lo SS, Sahgal A, Wang JZ, Mayr NA, Sloan A, Mendel E, Chang EL. Stereotactic body radiation therapy for spinal metastases. Discov Med. 2010 Apr;9(47):289-96.
PubMed 20423672
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated Stereotactic Radiation Treatments (SBRT) on Children, Teenagers and Young Adults Malignant Tumors
- ClinicalTrials.gov ID
- NCT02013297
- Acronym / sponsor ID
- SBRT / SBRT
- Conditions
- Brain Metastasis, Spinal Tumors, Lung Tumors, Ependymoma
- Keywords
- Pediatrics, SBRT, Brain metastasis, Pulmonary metastasis, Spinal metastasis, Pulmonary primary tumor, Spinal primary tumor, Relapsed ependymoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 3 Dec 2013 (actual)
- Primary completion
- 3 Apr 2020 (actual)
- Study completion
- 12 Oct 2021 (actual)
- First posted
- 17 Dec 2013 (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 purpose of this study is to evaluate the efficacy of hypofractionated stereotactic radiation treatments (SBRT) on children, teenagers and young adults malignant tumors.
Detailed description
SBRT (Stereotactic Body Radiation Therapy) is a radiotherapy treatment which involves the delivery of a single high dose radiation treatment or a few fractionated radiation treatments (usually up to 5). A high potent biological dose of radiation is delivered to the tumor improving the cure rates for the tumor, in a manner previously not achievable by standard conventional radiation therapy.
For adult patients, the "Haute Authorité de Santé" (HAS) validates some indications for this treatment which are the followings :
- Few primary or secondary brain tumors, which cannot be surgically removed
- Spinal tumors
- Primary bronchopulmonary tumors T1 T2 N0 M0 and pulmonary metastasis with slow growth and controled primary tumor.
For pediatrics patients, no indication is now validated by HAS. Indications validated for adults are rare in pediatrics but not exceptional, and in such cases efficient alternative treatments does not exist.
In consequence, and regarding the good results obtained in adult patients, it seems very important to validate the efficacy of this treatment on pediatrics population
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT treatment | Experimental | Radiation: SBRT treatmentAccording to the site to irradiate and to local constraints, SBRT consist in 1 to 8 fractions of 5 to 18 Gy |
Who may qualify
- Ages
- 18 months to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (33 listed)
- 18 months ≤ age ≤ 20 years
- Malignant primary tumor, histologically or cytologically proven
- Systemic disease under control or with slow evolution
- Written indication of SBRT according to local pediatrics meeting and national Radiotherapy (RT) web conference
- Performance Status ≤ 2 according to Eastern Cooperative Oncology Group (ECOG)
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 |
|---|---|---|
| SBRT treatmentFor Brain metastasis the SBRT treatment consists on 3 fractions of 8 Gy or 5 fractions of 7 Gy or 1 fraction of 18 Gy for a single metastasis which is less than 20 mm. For primary or secondary pulmonary tumors the SBRT treatment consists on 3 fractions of 15 Gy or 5 fractions of 10 Gy for peripheral lesions and on 5 fractions of 8 Gy for proximal lesions. For primary or secondary spinal or para-spinal tumors the SBRT treatment consists on 3 fractions of 9 Gy or 5 fractions of 7 Gy. For previously irradiated tumors (same locations) the SBRT treatment consists on 5 to 8 fractions of 5 Gy. For relapsed Ependymoma previously irradiated the SBRT treatment will be allocated by surgical stratified randomization and consists on either 3 fractions of 8 Gy or 5 fractions of 5 Gy. | Radiation | SBRT treatment |
Primary outcome
Efficacy of SBRT assessed 6 months after treatment
Time frame: 6 months after inclusion
The treatment efficacy is assessed by calculation of local control rate of irradiated locations according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria (complete response + partial response + stable disease)
8 secondary outcomes
Efficacy of SBRT assessed between 1,5 and 3 months after treatment
Time frame: Between 1,5 and 3 months after inclusion
Progressive Free Survival
Time frame: From the date of inclusion to the date of progression
Overall Survival
Time frame: From the date of inclusion to the date of death (Up to 5 years since the first inclusion)
Short time Safety profile of SBRT
Time frame: From inclusion to 3 months after inclusion
Long term Safety profile of SBRT
Time frame: after 24 months after inclusion
Efficacy of SBRT assessed 12 months after treatment
Time frame: 12 months after inclusion
Efficacy of SBRT assessed 24 months after treatment
Time frame: 24 months after inclusion
Medium time Safety profile of SBRT
Time frame: Between 3 months and 24 months after inclusion
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 8 Mar 2022.
- Background: PubMed 18725106Timmerman RD. An overview of hypofractionation and introduction to this issue of seminars in radiation oncology. Semin Radiat Oncol. 2008 Oct;18(4):215-22. doi: 10.1016/j.semradonc.2008.04.001. No abstract available.
- BackgroundRapport ANAES : Evaluation clinique et économique de la radiochirurgie intra cranienne en conditions stéréotaxique - Rapport ANAES/Service évaluation des technologies-évaluation économique: 2000.
- BackgroundRapport HAS : Radiothérapie extra crânienne en conditions stéréotaxiques - Décembre 2006: 2006.
- Background: PubMed 21528665Maranzano E, Anselmo P, Casale M, Trippa F, Carletti S, Principi M, Loreti F, Italiani M, Caserta C, Giorgi C. Treatment of recurrent glioblastoma with stereotactic radiotherapy: long-term results of a mono-institutional trial. Tumori. 2011 Jan-Feb;97(1):56-61. doi: 10.1177/030089161109700111.
- Background: PubMed 21052773Minniti G, Armosini V, Salvati M, Lanzetta G, Caporello P, Mei M, Osti MF, Maurizi RE. Fractionated stereotactic reirradiation and concurrent temozolomide in patients with recurrent glioblastoma. J Neurooncol. 2011 Jul;103(3):683-91. doi: 10.1007/s11060-010-0446-8. Epub 2010 Nov 5.
- Background: PubMed 21517131Torok JA, Wegner RE, Mintz AH, Heron DE, Burton SA. Re-irradiation with radiosurgery for recurrent glioblastoma multiforme. Technol Cancer Res Treat. 2011 Jun;10(3):253-8. doi: 10.7785/tcrt.2012.500200.
- Background: PubMed 20039045Zacharoulis S, Ashley S, Moreno L, Gentet JC, Massimino M, Frappaz D. Treatment and outcome of children with relapsed ependymoma: a multi-institutional retrospective analysis. Childs Nerv Syst. 2010 Jul;26(7):905-11. doi: 10.1007/s00381-009-1067-4. Epub 2009 Dec 29.
- Background: PubMed 21039163Kano H, Yang HC, Kondziolka D, Niranjan A, Arai Y, Flickinger JC, Lunsford LD. Stereotactic radiosurgery for pediatric recurrent intracranial ependymomas. J Neurosurg Pediatr. 2010 Nov;6(5):417-23. doi: 10.3171/2010.8.PEDS10252.
- Background: PubMed 19260098Liu AK, Foreman NK, Gaspar LE, Trinidad E, Handler MH. Maximally safe resection followed by hypofractionated re-irradiation for locally recurrent ependymoma in children. Pediatr Blood Cancer. 2009 Jul;52(7):804-7. doi: 10.1002/pbc.21982.
- Background: PubMed 17854490Combs SE, Behnisch W, Kulozik AE, Huber PE, Debus J, Schulz-Ertner D. Intensity Modulated Radiotherapy (IMRT) and Fractionated Stereotactic Radiotherapy (FSRT) for children with head-and-neck-rhabdomyosarcoma. BMC Cancer. 2007 Sep 13;7:177. doi: 10.1186/1471-2407-7-177.
- Background: PubMed 15558704Giller CA, Berger BD, Pistenmaa DA, Sklar F, Weprin B, Shapiro K, Winick N, Mulne AF, Delp JL, Gilio JP, Gall KP, Dicke KA, Swift D, Sacco D, Harris-Henderson K, Bowers D. Robotically guided radiosurgery for children. Pediatr Blood Cancer. 2005 Sep;45(3):304-10. doi: 10.1002/pbc.20267.
- Background: PubMed 8692387Grabb PA, Lunsford LD, Albright AL, Kondziolka D, Flickinger JC. Stereotactic radiosurgery for glial neoplasms of childhood. Neurosurgery. 1996 Apr;38(4):696-701; discussion 701-2.
Related trials for Brain Metastasis
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
Epidural Hydroxyethyl Starch for Post-Dural Puncture Headache in Parturients
Parturients, Accidental Puncture of Dura During Anaesthesia
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
RecruitingPhase 2/3
RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive
HER2-positive Breast Cancer
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.
Line CLAUDE, Doctor principal investigator
Centre Leon Berard
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBRT treatment in people with Brain Metastasis and Spinal Tumors, run by Centre Leon Berard at 15 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 33 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: finished, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
Efficacy of SBRT assessed 6 months after treatment (time frame: 6 months after inclusion). 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 NCT02013297, which also lists 22 linked publications.
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 8 Mar 2022.