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

N/ACompletedNCT02013297

Centre Leon Berard61 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Brain Metastasis Spinal Tumors Lung Tumors Ependymoma

Interventions

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.

Eligibility

Sex: ALLMin age: 18 MonthsMax age: 20 Years

Medical Language ↔ Plain English

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

Locations (15)

Centre Antoine Lacassagne

Nice, Alpes Maritimes, France

Centre Paul Strauss

Strasbourg, Bas-Rhin, France

Hôpital La Timone

Marseille, Bouches Du Rhône, France

Outcomes

Primary Outcomes

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)

Time frame: 6 months after inclusion

Secondary Outcomes

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

Time frame: 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)

Time frame: 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)

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

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

Time frame: From inclusion to 3 months after inclusion

Long term Safety profile of SBRT

Data from ClinicalTrials.gov

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