Clinical trial NCT02013297: Study of SBRT Efficacy on Intra and Extra -Cranial Tumors or Metastasis in Pediatrics Population (SBRT Pediatrics)
Official title: Hypofractionated Stereotactic Radiation Treatments (SBRT) on Children, Teenagers and Young Adults Malignant Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Relapsed irradiated tumors
Local control rate
Safety
Overall survival
Progression Free Survival
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2013-12-17
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility 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 :

* 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

Primary outcomes:
measure: Efficacy of SBRT assessed 6 months after treatment
timeFrame: 6 months after inclusion
Secondary outcomes:
measure: Efficacy of SBRT assessed between 1,5 and 3 months after treatment
timeFrame: Between 1,5 and 3 months after inclusion
measure: Progressive Free Survival
timeFrame: From the date of inclusion to the date of progression
measure: Overall Survival
timeFrame: From the date of inclusion to the date of death (Up to 5 years since the first inclusion)
measure: Short time Safety profile of SBRT
timeFrame: From inclusion to 3 months after inclusion
measure: Long term Safety profile of SBRT
timeFrame: after 24 months after inclusion
measure: Efficacy of SBRT assessed 12 months after treatment
timeFrame: 12 months after inclusion
measure: Efficacy of SBRT assessed 24 months after treatment
timeFrame: 24 months after inclusion
measure: Medium time Safety profile of SBRT
timeFrame: Between 3 months and 24 months after inclusion
Other outcomes:
measure: SBRT treatment and toxicities related costs for 6 months after SBRT
timeFrame: 6 months after inclusion
measure: Cost/Efficacy ratio between 2 modalities of SBRT treatment of ependymoma at 6 months after treatment
timeFrame: 6 months after inclusion
measure: Cost/Efficacy ratio between 2 modalities of SBRT treatment of ependymoma at 12 months after treatment
timeFrame: 12 months after inclusion
measure: Cost/Efficacy ratio between 2 modalities of SBRT treatment of ependymoma at 24 months after treatment
timeFrame: 24 months after inclusion
Locations:
city: Nice
country: France
facility: Centre Antoine Lacassagne
state: Alpes Maritimes
city: Strasbourg
country: France
facility: Centre Paul Strauss
state: Bas-Rhin
city: Marseille
country: France
facility: Hôpital La Timone
state: Bouches Du Rhône
city: Caen
country: France
facility: Centre François Baclesse
state: Calvados
city: Bordeaux
country: France
facility: CHU Bordeaux - Hôpital Saint André
state: Gironde
city: Toulouse
country: France
facility: Centre Claudius Régaud
state: Haute Garonne
city: Montpellier
country: France
facility: Institut de Cancérologie de Montpellier
state: Hérault
city: Paris
country: France
facility: Institut Curie
state: Ile De France
city: Rennes
country: France
facility: Centre Eugène Marquis
state: Ille Et Vilaine
city: Tours
country: France
facility: CHRU de Tours - Hôpital Bretonneau
state: Indre Et Loire
city: Saint Herblain
country: France
facility: Institut de Cancérologie de l'Ouest René Gauducheau
state: Loire Atlantique
city: Vandoeuvre-Lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
state: Meurthe Et Moselle
city: Lille
country: France
facility: Centre Oscar Lambret
state: Nord
city: Lyon
country: France
facility: Centre Léon Bérard
state: Rhône
city: Villejuif
country: France
facility: Institut Gustave Roussy
state: Val De Marne
Study officials:
affiliation: Centre Leon Berard
name: Line CLAUDE, Doctor
role: PRINCIPAL_INVESTIGATOR
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