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

Léon Bérard Center

Status

Completed

Conditions

Lung Tumors

Brain Metastasis

Spinal Tumors

Ependymoma

Treatments

Radiation: SBRT treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT02013297

SBRT

Details and patient eligibility

About

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

Full 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

Enrollment

61 patients

Sex

All

Ages

18 months to 20 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 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 :