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Long Term Brain Toxicity of Chemotherapy in Patients Treated for a Bone TumorDuring Childhood or Adolescence (OSE)

Primary Purpose

Adults Treated During Childhood or Adolescence for a Malignant Bone Tumor (Osteosarcoma and Ewing Sarcoma)

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
Sponsored by
Gustave Roussy, Cancer Campus, Grand Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Adults Treated During Childhood or Adolescence for a Malignant Bone Tumor (Osteosarcoma and Ewing Sarcoma)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

For study OSE A and B

  • Patients treated for a bone sarcoma: Ewing or osteosarcoma
  • Age under 19 years at initial diagnosis
  • Treated in the Pediatric Oncology Department of Gustave

For patients diagnosed between 01.01.2001 and 31.12.2010: patients alive in complete remission at least 5 years after diagnosis

  • Treated with at least one course of HDMTX for osteosarcoma
  • Treated without HDMTX for Ewing sarcoma
  • Time interval between the end of treatment and inclusion >10 y
  • Age > 21 y at inclusion
  • Patients with informed consent signed
  • Patient under guardianship
  • Affiliated to French health insurance or beneficiary of the same or equivalent

For study OSE- B only:

  • Treated with at least 8 courses of HDMTX for osteosarcoma
  • Treated without HDMTX for Ewing sarcoma
  • Patients with Ewing sarcoma will have to be matched with osteosarcoma patients according to age at the time of treatment, sex, and duration of follow-up
  • School level equivalent of at least the end of primary school

Exclusion Criteria:

For study OSE A and B

  • Brain radiotherapy
  • Previous relapse except those treated by local treatment without any chemotherapy
  • Second malignancy treated with chemotherapy
  • High dose chemotherapy with stem cell support
  • Non-French speaking patients
  • Pregnant and breastfeeding women

For study OSE- B only:

- Patient deprived of his liberty by a judicial or administrative decision

Sites / Locations

  • Gustave RoussyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

scores obtained in FactCOG as a whole and in each subscale
Primary analysis will be performed on all patients included in the study, including history of Ewing (treated without HDMTX) and osteosarcoma (treated with HDMTX). This population is the main analysis population of the study.

Secondary Outcome Measures

Full Information

First Posted
September 27, 2021
Last Updated
September 27, 2021
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05071001
Brief Title
Long Term Brain Toxicity of Chemotherapy in Patients Treated for a Bone TumorDuring Childhood or Adolescence
Acronym
OSE
Official Title
Long Term Brain Toxicity of Chemotherapy in Patients Treated for a Bone TumorDuring Childhood or Adolescence
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 19, 2021 (Actual)
Primary Completion Date
April 7, 2025 (Anticipated)
Study Completion Date
April 7, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To assess the neurocognitive outcomes in patients treated with chemotherapy for a malignant bone tumor during childhood and adolescence and the factors associated with neurocognitive impairment and/or complaints

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adults Treated During Childhood or Adolescence for a Malignant Bone Tumor (Osteosarcoma and Ewing Sarcoma)

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
530 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
MRI
Intervention Description
This assessment will be planned in the year after the consent signAll patients will have one brain MRI performed in Henri Mondor Hospital on a 3T MR unit (Skyra, Siemens, Erlangen). The procedure will include: a 3D-FLAIR imaging a morphometric study based on a 3DT1 MPRAGE gradient echo sequence (TR / TI / TE = 2300/900 /2.9 ms) an analysis of the anatomic connectivity of the patient's brain assessed using a 1.5mm isotopic DTI with a high number of directions (HARDI / 65 directions / b=1500s/mm2). An evaluation of neuronal dysfunction using MR Spectroscopy. Spectroscopic data will be collected using a 2D CSI laser with a short TE technique. Magnetization transfer imaging providing information about integrity of membranes.
Primary Outcome Measure Information:
Title
scores obtained in FactCOG as a whole and in each subscale
Description
Primary analysis will be performed on all patients included in the study, including history of Ewing (treated without HDMTX) and osteosarcoma (treated with HDMTX). This population is the main analysis population of the study.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: For study OSE A and B Patients treated for a bone sarcoma: Ewing or osteosarcoma Age under 19 years at initial diagnosis Treated in the Pediatric Oncology Department of Gustave For patients diagnosed between 01.01.2001 and 31.12.2010: patients alive in complete remission at least 5 years after diagnosis Treated with at least one course of HDMTX for osteosarcoma Treated without HDMTX for Ewing sarcoma Time interval between the end of treatment and inclusion >10 y Age > 21 y at inclusion Patients with informed consent signed Patient under guardianship Affiliated to French health insurance or beneficiary of the same or equivalent For study OSE- B only: Treated with at least 8 courses of HDMTX for osteosarcoma Treated without HDMTX for Ewing sarcoma Patients with Ewing sarcoma will have to be matched with osteosarcoma patients according to age at the time of treatment, sex, and duration of follow-up School level equivalent of at least the end of primary school Exclusion Criteria: For study OSE A and B Brain radiotherapy Previous relapse except those treated by local treatment without any chemotherapy Second malignancy treated with chemotherapy High dose chemotherapy with stem cell support Non-French speaking patients Pregnant and breastfeeding women For study OSE- B only: - Patient deprived of his liberty by a judicial or administrative decision
Facility Information:
Facility Name
Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brice Fresneau, Dr
Phone
01 42 11 42 47
Email
brice.fresneau@gustaveroussy.fr
First Name & Middle Initial & Last Name & Degree
Lila SAIDOUN
Phone
01 42 11 42 11
Ext
23820
Email
Lila.saidoun@gustaveroussy.fr

12. IPD Sharing Statement

Learn more about this trial

Long Term Brain Toxicity of Chemotherapy in Patients Treated for a Bone TumorDuring Childhood or Adolescence

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