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Study of SBRT Efficacy on Intra and Extra -Cranial Tumors or Metastasis in Pediatrics Population (SBRT Pediatrics) (SBRT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02013297
Recruitment Status : Active, not recruiting
First Posted : December 17, 2013
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Leon Berard

Brief 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.

Condition or disease Intervention/treatment Phase
Brain Metastasis Spinal Tumors Lung Tumors Ependymoma Radiation: SBRT treatment Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hypofractionated Stereotactic Radiation Treatments (SBRT) on Children, Teenagers and Young Adults Malignant Tumors
Actual Study Start Date : December 3, 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SBRT treatment
According to the site to irradiate and to local constraints, SBRT consist in 1 to 8 fractions of 5 to 18 Gy
Radiation: SBRT treatment

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.





Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Efficacy of SBRT assessed between 1,5 and 3 months after treatment [ Time Frame: Between 1,5 and 3 months after inclusion ]
    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

  2. Progressive Free Survival [ Time Frame: From the date of inclusion to the date of progression ]
    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)

  3. Overall Survival [ Time Frame: From the date of inclusion to the date of death (Up to 5 years since the first inclusion) ]
    Calculated from the date of inclusion to the date of death from any cause (Up to 5 years since the first inclusion)

  4. Short time Safety profile of SBRT [ Time Frame: From inclusion to 3 months after inclusion ]
    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

  5. Long term Safety profile of SBRT [ Time Frame: after 24 months after inclusion ]
    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

  6. Efficacy of SBRT assessed 12 months after treatment [ Time Frame: 12 months after inclusion ]
    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

  7. Efficacy of SBRT assessed 24 months after treatment [ Time Frame: 24 months after inclusion ]
    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

  8. Medium time Safety profile of SBRT [ Time Frame: Between 3 months and 24 months after inclusion ]
    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


Other Outcome Measures:
  1. SBRT treatment and toxicities related costs for 6 months after SBRT [ Time Frame: 6 months after inclusion ]
    The SBRT treatment related costs will be evaluated by a "microcosting" method which take into account, in particular, the irradiation duration seance, the time for the mobilized staff, the kind of equipment required, the duration of related AE hospitalizations.

  2. Cost/Efficacy ratio between 2 modalities of SBRT treatment of ependymoma at 6 months after treatment [ Time Frame: 6 months after inclusion ]

    2 modalities of SBRT are compared in patients with an ependymoma (3 fractions of 8 Gy versus 5 fractions of 5 Gy). It will be calculated the cost/efficacity ratio for the avoided toxicity 6 months after SBRT.

    The costs will be evaluated by the data from french social security system, from homogeneous group of patients and from general classification of professional acts


  3. Cost/Efficacy ratio between 2 modalities of SBRT treatment of ependymoma at 12 months after treatment [ Time Frame: 12 months after inclusion ]

    2 modalities of SBRT are compared in patients with an ependymoma (3 fractions of 8 Gy versus 5 fractions of 5 Gy). It will be calculated :

    • the cost/efficacity per gained year of life without relapse after 12 months after SBRT
    • the cost/efficacity per gained year of life without disease after 12 months after SBRT.

    The costs will be evaluated by the data from french social security system, from homogeneous group of patients and from general classification of professional acts


  4. Cost/Efficacy ratio between 2 modalities of SBRT treatment of ependymoma at 24 months after treatment [ Time Frame: 24 months after inclusion ]

    2 modalities of SBRT are compared in patients with an ependymoma (3 fractions of 8 Gy versus 5 fractions of 5 Gy). It will be calculated :

    • the cost/efficacity per gained year of life without relapse after 24 months after SBRT
    • the cost/efficacity per gained year of life without disease after 24 months after SBRT.

    The costs will be evaluated by the data from french social security system, from homogeneous group of patients and from general classification of professional acts




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  • 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

    • 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.

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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02013297


Locations
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France
Centre Antoine Lacassagne
Nice, Alpes Maritimes, France, 06050
Centre Paul Strauss
Strasbourg, Bas-Rhin, France, 67805
Hôpital La Timone
Marseille, Bouches Du Rhône, France, 13500
Centre François Baclesse
Caen, Calvados, France, 14000
CHU Bordeaux - Hôpital Saint André
Bordeaux, Gironde, France, 33000
Centre Claudius Régaud
Toulouse, Haute Garonne, France, 31052
Institut de Cancérologie de Montpellier
Montpellier, Hérault, France, 34298
Institut Curie
Paris, Ile De France, France, 75231
Centre Eugène Marquis
Rennes, Ille Et Vilaine, France, 35062
CHRU de Tours - Hôpital Bretonneau
Tours, Indre Et Loire, France, 37044
Institut de Cancérologie de l'Ouest René Gauducheau
Saint Herblain, Loire Atlantique, France, 44805
Institut de Cancérologie de Lorraine
Vandoeuvre-Lès-Nancy, Meurthe Et Moselle, France, 54511
Centre Oscar Lambret
Lille, Nord, France, 59020
Centre Léon Bérard
Lyon, Rhône, France, 69373
Institut Gustave Roussy
Villejuif, Val De Marne, France, 94805
Sponsors and Collaborators
Centre Leon Berard
Investigators
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Principal Investigator: Line CLAUDE, Doctor Centre Leon Berard
Publications:
Rapport 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.

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Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT02013297    
Other Study ID Numbers: SBRT
First Posted: December 17, 2013    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: July 2020
Keywords provided by Centre Leon Berard:
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
Additional relevant MeSH terms:
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Neoplasms
Neoplasm Metastasis
Ependymoma
Neoplastic Processes
Pathologic Processes
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue