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

Primary Purpose

Brain Metastasis, Spinal Tumors, Lung Tumors

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SBRT treatment
Sponsored by
Centre Leon Berard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Metastasis focused on measuring 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

Eligibility Criteria

18 Months - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Antoine Lacassagne
  • Centre Paul Strauss
  • Hôpital La Timone
  • Centre François Baclesse
  • CHU Bordeaux - Hôpital Saint André
  • Centre Claudius Régaud
  • Institut de Cancérologie de Montpellier
  • Institut Curie
  • Centre Eugène Marquis
  • CHRU de Tours - Hôpital Bretonneau
  • Institut de Cancérologie de l'Ouest René Gauducheau
  • Institut de Cancérologie de Lorraine
  • Centre Oscar Lambret
  • Centre Léon Bérard
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SBRT treatment

Arm Description

According to the site to irradiate and to local constraints, SBRT consist in 1 to 8 fractions of 5 to 18 Gy

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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)
Overall Survival
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
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
Long term Safety profile of SBRT
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
Efficacy of SBRT assessed 12 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) at 12 months after treatment
Efficacy of SBRT assessed 24 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) at 24 months after treatment
Medium time Safety profile of SBRT
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

Full Information

First Posted
December 5, 2013
Last Updated
March 7, 2022
Sponsor
Centre Leon Berard
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1. Study Identification

Unique Protocol Identification Number
NCT02013297
Brief Title
Study of SBRT Efficacy on Intra and Extra -Cranial Tumors or Metastasis in Pediatrics Population (SBRT Pediatrics)
Acronym
SBRT
Official Title
Hypofractionated Stereotactic Radiation Treatments (SBRT) on Children, Teenagers and Young Adults Malignant Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 3, 2013 (Actual)
Primary Completion Date
April 3, 2020 (Actual)
Study Completion Date
October 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Leon Berard

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SBRT treatment
Arm Type
Experimental
Arm Description
According to the site to irradiate and to local constraints, SBRT consist in 1 to 8 fractions of 5 to 18 Gy
Intervention Type
Radiation
Intervention Name(s)
SBRT treatment
Intervention Description
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 Outcome Measure Information:
Title
Efficacy of SBRT assessed 6 months after treatment
Description
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 Outcome Measure Information:
Title
Efficacy of SBRT assessed between 1,5 and 3 months after treatment
Description
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
Title
Progressive Free Survival
Description
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
Title
Overall Survival
Description
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)
Title
Short time Safety profile of SBRT
Description
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
Title
Long term Safety profile of SBRT
Description
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
Time Frame
after 24 months after inclusion
Title
Efficacy of SBRT assessed 12 months after treatment
Description
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
Time Frame
12 months after inclusion
Title
Efficacy of SBRT assessed 24 months after treatment
Description
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
Time Frame
24 months after inclusion
Title
Medium time Safety profile of SBRT
Description
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
Time Frame
Between 3 months and 24 months after inclusion
Other Pre-specified Outcome Measures:
Title
SBRT treatment and toxicities related costs for 6 months after SBRT
Description
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.
Time Frame
6 months after inclusion
Title
Cost/Efficacy ratio between 2 modalities of SBRT treatment of ependymoma at 6 months after treatment
Description
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
Time Frame
6 months after inclusion
Title
Cost/Efficacy ratio between 2 modalities of SBRT treatment of ependymoma at 12 months after treatment
Description
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
Time Frame
12 months after inclusion
Title
Cost/Efficacy ratio between 2 modalities of SBRT treatment of ependymoma at 24 months after treatment
Description
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
Time Frame
24 months after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Line CLAUDE, Doctor
Organizational Affiliation
Centre Leon Berard
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Antoine Lacassagne
City
Nice
State/Province
Alpes Maritimes
ZIP/Postal Code
06050
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
State/Province
Bas-Rhin
ZIP/Postal Code
67805
Country
France
Facility Name
Hôpital La Timone
City
Marseille
State/Province
Bouches Du Rhône
ZIP/Postal Code
13500
Country
France
Facility Name
Centre François Baclesse
City
Caen
State/Province
Calvados
ZIP/Postal Code
14000
Country
France
Facility Name
CHU Bordeaux - Hôpital Saint André
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33000
Country
France
Facility Name
Centre Claudius Régaud
City
Toulouse
State/Province
Haute Garonne
ZIP/Postal Code
31052
Country
France
Facility Name
Institut de Cancérologie de Montpellier
City
Montpellier
State/Province
Hérault
ZIP/Postal Code
34298
Country
France
Facility Name
Institut Curie
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75231
Country
France
Facility Name
Centre Eugène Marquis
City
Rennes
State/Province
Ille Et Vilaine
ZIP/Postal Code
35062
Country
France
Facility Name
CHRU de Tours - Hôpital Bretonneau
City
Tours
State/Province
Indre Et Loire
ZIP/Postal Code
37044
Country
France
Facility Name
Institut de Cancérologie de l'Ouest René Gauducheau
City
Saint Herblain
State/Province
Loire Atlantique
ZIP/Postal Code
44805
Country
France
Facility Name
Institut de Cancérologie de Lorraine
City
Vandoeuvre-Lès-Nancy
State/Province
Meurthe Et Moselle
ZIP/Postal Code
54511
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
State/Province
Nord
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
State/Province
Rhône
ZIP/Postal Code
69373
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
State/Province
Val De Marne
ZIP/Postal Code
94805
Country
France

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

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