Study of SBRT Efficacy on Intra and Extra -Cranial Tumors or Metastasis in Pediatrics Population (SBRT Pediatrics)
- Conditions
- Spinal TumorsLung TumorsEpendymomaBrain Metastasis
- Interventions
- Radiation: SBRT treatment
- Registration Number
- NCT02013297
- Lead Sponsor
- 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.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SBRT treatment SBRT treatment According to the site to irradiate and to local constraints, SBRT consist in 1 to 8 fractions of 5 to 18 Gy
- Primary Outcome Measures
Name Time Method Efficacy of SBRT assessed 6 months after treatment 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
Name Time Method Efficacy of SBRT assessed 12 months after treatment 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
Efficacy of SBRT assessed between 1,5 and 3 months after treatment 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
Overall Survival 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)
Short time Safety profile of SBRT 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
Efficacy of SBRT assessed 24 months after treatment 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
Progressive Free Survival 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)
Medium time Safety profile of SBRT 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
Long term Safety profile of SBRT 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
Trial Locations
- Locations (15)
Institut de Cancérologie de Montpellier
🇫🇷Montpellier, Hérault, France
Centre Léon Bérard
🇫🇷Lyon, Rhône, France
Institut de Cancérologie de Lorraine
🇫🇷Vandoeuvre-Lès-Nancy, Meurthe Et Moselle, France
Institut Gustave Roussy
🇫🇷Villejuif, Val De Marne, France
Centre Eugène Marquis
🇫🇷Rennes, Ille Et Vilaine, France
Centre Oscar Lambret
🇫🇷Lille, Nord, France
Centre Antoine Lacassagne
🇫🇷Nice, Alpes Maritimes, France
Centre Paul Strauss
🇫🇷Strasbourg, Bas-Rhin, France
Hôpital La Timone
🇫🇷Marseille, Bouches Du Rhône, France
Centre François Baclesse
🇫🇷Caen, Calvados, France
CHU Bordeaux - Hôpital Saint André
🇫🇷Bordeaux, Gironde, France
Centre Claudius Régaud
🇫🇷Toulouse, Haute Garonne, France
Institut Curie
🇫🇷Paris, Ile De France, France
CHRU de Tours - Hôpital Bretonneau
🇫🇷Tours, Indre Et Loire, France
Institut de Cancérologie de l'Ouest René Gauducheau
🇫🇷Saint Herblain, Loire Atlantique, France