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Completed

NCT Number: NCT02013297

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

The purpose of this study is to evaluate the efficacy of hypofractionated stereotactic radiation treatments (SBRT) on children, teenagers and young adults malignant tumors.

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Key information

Conditions

Brain Metastasis Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Ependymoma Glioma Lung Diseases Lung Neoplasms Lung Tumors Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Respiratory Tract Diseases Respiratory Tract Neoplasms Spinal Cord Diseases Spinal Cord Neoplasms Spinal Tumors Thoracic Neoplasms

Age range

18 month–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Antoine Lacassagne, Nice, Alpes Maritimes, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

SBRT treatment

Radiation

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 outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Registry information

Official study title

Hypofractionated Stereotactic Radiation Treatments (SBRT) on Children, Teenagers and Young Adults Malignant Tumors

Acronym: SBRT

Important dates

Study start
2013
Primary completion
2020
Study completion
2021
First posted
Dec 17, 2013
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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