Trial record 9 of 125 for:    Brain and Spinal Tumors

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Centre Leon Berard
Sponsor:
Information provided by (Responsible Party):
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT02013297
First received: December 5, 2013
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention
Brain Metastasis
Spinal Tumors
Lung Tumors
Ependymoma
Radiation: SBRT treatment

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hypofractionated Stereotactic Radiation Treatments (SBRT) on Children, Teenagers and Young Adults Malignant Tumors

Resource links provided by NLM:


Further study details as provided by Centre Leon Berard:

Primary Outcome Measures:
  • Efficacy of SBRT assessed 6 months after treatment [ Time Frame: 6 months after inclusion ] [ Designated as safety issue: No ]
    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 [ Time Frame: Between 1,5 and 3 months after inclusion ] [ Designated as safety issue: No ]
    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 [ Time Frame: From the date of inclusion to the date of progression ] [ Designated as safety issue: No ]
    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 [ Time Frame: From the date of inclusion to the date of death (Up to 5 years since the first inclusion) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From inclusion to 3 months after inclusion ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: after 24 months after inclusion ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 12 months after inclusion ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 months after inclusion ] [ Designated as safety issue: No ]
    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 [ Time Frame: Between 3 months and 24 months after inclusion ] [ Designated as safety issue: Yes ]
    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


Other Outcome Measures:
  • SBRT treatment and toxicities related costs for 6 months after SBRT [ Time Frame: 6 months after inclusion ] [ Designated as safety issue: No ]
    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.

  • Cost/Efficacy ratio between 2 modalities of SBRT treatment of ependymoma at 6 months after treatment [ Time Frame: 6 months after inclusion ] [ Designated as safety issue: No ]

    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


  • Cost/Efficacy ratio between 2 modalities of SBRT treatment of ependymoma at 12 months after treatment [ Time Frame: 12 months after inclusion ] [ Designated as safety issue: No ]

    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


  • Cost/Efficacy ratio between 2 modalities of SBRT treatment of ependymoma at 24 months after treatment [ Time Frame: 24 months after inclusion ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 80
Study Start Date: December 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SBRT treatment
According to the site to irradiate and to local constraints, SBRT consist in 1 to 8 fractions of 5 to 18 Gy
Radiation: SBRT treatment

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.


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

Ages Eligible for Study:   18 Months to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02013297

Contacts
Contact: Line CLAUDE, Doctor +33478782652 line.claude@lyon.unicancer.fr
Contact: Christian CARRIE, Doctor +33478782652 christian.carrie@lyon.unicancer.fr

Locations
France
Centre Antoine Lacassagne Not yet recruiting
Nice, Alpes Maritimes, France, 06050
Contact: Pierre-Yves BONDIAU, Doctor    +33492031261    pierre-yves.bondiau@nice.unicancer.fr   
Principal Investigator: Pierre-Yves BONDIAU, Doctor         
Sub-Investigator: Juliette THARIAT, Doctor         
Centre Paul Strauss Not yet recruiting
Strasbourg, Bas-Rhin, France, 67805
Contact: Georges NOEL, Doctor    +33388252471    gnoel@strasbourg.unicancer.fr   
Principal Investigator: Georges NOEL, Doctor         
Hôpital La Timone Not yet recruiting
Marseille, Bouches du Rhône, France, 13500
Contact: Laëtitia PADOVANI, Doctor    +33491384334    laetitia.padovani@ap-hm.fr   
Principal Investigator: Laëtitia PADOVANI, Doctor         
Centre François Baclesse Not yet recruiting
Caen, Calvados, France, 14000
Contact: Jean-Louis HABRAND, Doctor    +33231455020    jl.habrand@baclesse.fr   
Principal Investigator: Jean-Louis HABRAND, Doctor         
Sub-Investigator: Stephan DINU, Doctor         
CHU Bordeaux - Hôpital Saint André Not yet recruiting
Bordeaux, Gironde, France, 33000
Contact: Aymeri HUCHET    +33556795679    aymeri.huchet@chu.bordeaux.fr   
Principal Investigator: Aymeri HUCHET, Doctor         
Centre Claudius Régaud Recruiting
Toulouse, Haute Garonne, France, 31052
Contact: Anne LAPRIE, Doctor    +33561424188    laprie.anne@claudiusregaud.fr   
Principal Investigator: Anne LAPRIE, Doctor         
Institut de Cancérologie de Montpellier Not yet recruiting
Montpellier, Hérault, France, 34298
Contact: Christine KERR, Doctor    +33467613132    christine.kerr@montpellier.unicancer.fr   
Principal Investigator: Christine KERR, Doctor         
Institut Curie Not yet recruiting
Paris, Ile de France, France, 75231
Contact: Claire ALAPETITE, Doctor    +33144324634    claire.alapetite@curie.net   
Principal Investigator: Claire ALAPETITE, Doctor         
Sub-Investigator: Sylvie HELFRE, Doctor         
Centre Eugène Marquis Recruiting
Rennes, Ille et Vilaine, France, 35062
Contact: Julie LESEUR, Doctor    +33299253042    j.leseur@rennes.fnclcc.fr   
Principal Investigator: Julie LESEUR, Doctor         
CHRU de Tours - Hôpital Bretonneau Not yet recruiting
Tours, Indre et Loire, France, 37044
Contact: Amandine RUFFIER-LOUBIERE, Dr    + 33247479999    a.ruffier-loubiere@chu-tours.fr   
Principal Investigator: Amandine RUFFIER-LOUBIERE, Doctor         
Sub-Investigator: Sophie CHAPET, Doctor         
Institut de Cancérologie de l'Ouest René Gauducheau Recruiting
Saint Herblain, Loire Atlantique, France, 44805
Contact: Stéphane SUPIOT, Doctor    +33240679900    stephane.supiot@ico.unicancer.fr   
Principal Investigator: Stéphane SUPIOT, Doctor         
Sub-Investigator: Marc-André MAHE, Doctor         
Institut de Cancérologie de Lorraine Not yet recruiting
Vandoeuvre-Lès-Nancy, Meurthe et Moselle, France, 54511
Contact: Valérie BERNIER, Doctor    +33383598533    v.bernier@nancy.fnclcc.fr   
Principal Investigator: Valérie BERNIER, Doctor         
Centre Oscar Lambret Not yet recruiting
Lille, Nord, France, 59020
Contact: Bernard COCHE-DEQUEANT, Doctor    +33320295911    b-coche@o-lambret.fr   
Principal Investigator: Bernard COCHE-DEQUEANT, Doctor         
Centre Léon Bérard Recruiting
Lyon, Rhône, France, 69373
Contact: Line CLAUDE, Doctor    +33478782652    line.claude@lyon.unicancer.fr   
Contact: Christian CARRIE, Doctor    +33478782652    christian.carrie@lyon.unicancer.fr   
Principal Investigator: Line CLAUDE, Doctor         
Sub-Investigator: Christian CARRIE, Doctor         
Institut Gustave Roussy Not yet recruiting
Villejuif, Val de Marne, France, 94805
Contact: Stéphanie BOLLE, Doctor    +33142114995    stephanie.bolle@igr.fr   
Principal Investigator: Stéphanie BOLLE, Doctor         
Sub-Investigator: Frédéric DHERMAIN, Doctor         
Sponsors and Collaborators
Centre Leon Berard
Investigators
Principal Investigator: Line CLAUDE, Doctor Centre Léon Bérard
  More Information

Publications:
Kano H, Yang HC, Kondziolka D, Niranjan A, Arai Y, Flickinger JC, Lunsford LD: Stereotactic radiosurgery for pediatric recurrent intracranial ependymomas. J Neurosurg Pediatr 2010;6:417-423.

Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT02013297     History of Changes
Other Study ID Numbers: ET13-064
Study First Received: December 5, 2013
Last Updated: July 29, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Centre Leon Berard:
Brain metastasis
Spinal metastasis
Pulmonary primary tumor
Spinal primary tumor
Relapsed irradiated tumors
Pediatrics
SBRT
Pulmonary metastasis
Relapsed ependymoma
Local control rate
Safety
Overall survival
Progression Free Survival

Additional relevant MeSH terms:
Lung Neoplasms
Neoplasm Metastasis
Spinal Cord Neoplasms
Spinal Neoplasms
Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Central Nervous System Neoplasms
Nervous System Neoplasms
Spinal Cord Diseases
Bone Neoplasms
Spinal Diseases
Brain Diseases
Ependymoma
Glioma
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Bone Diseases

ClinicalTrials.gov processed this record on July 29, 2014