Back to resultsDose Escalation Radiotherapy With Modulation of Intensity and Integrated Boost (SIB-IMRT) in the Treatment of Glioblastomas in Adults (SIB-IMRT)
Primary Purpose
Glioblastoma
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
radiotherapy
temozolomide
Sponsored by
About this trial
This is an interventional treatment trial for Glioblastoma focused on measuring IMRT, Radiotherapy escalation dose, glioblastoma, escalation radiotherapy dose
Eligibility Criteria
Inclusion Criteria:
- Histopathologically proven diagnosis of glioblastoma (WHO grade IV astrocytoma)
- Diagnosis must be obtained by a stereotactic or surgical biopsy
- Age between 18 and 70
- Total or partial surgical resection deemed as not possible by a neurosurgeon
- OMS performance status 0 or 1
- Adequate blood function : absolute neutrophil count > 1.5 x 109/L, platelets count > 100 x 109/L platelets;
- Adequate liver function: bilirubin < 1.5 ULN (upper limit of normal), ALT and AST < 3 ULN,
- Adequate renal function: creatinine < 1.5 ULN
- Patient must have been informed and must have signed the specific informed consent form.
Exclusion Criteria:
- other malignancy histology
- resection of the brain tumor complete on MRI exploration
- patient unable to give informed consent
- patient presenting counter-indication to MRI exploration
- patient must not have received neither radiotherapy nor chemotherapy for that affection
- concomitant malignancy
- patient already enrolled in another biomedical study with an experimental molecule
- pregnant, nursing woman, or without contraception
- private individuals of freedom or under tutelage (including legal guardianship)
- psychiatric, behavioural disorders or geographical situation precluding the administration or follow-up of the protocol (including claustrophobia)
Sites / Locations
- Centre Georges François Leclerc
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
radiotherapy + temozolomide
Arm Description
Radiotherapy: dose given at PTV-g will be 70 Gy/28 fractions level 1 75 Gy/30 fractions level 2 80 Gy/32 fractions level 3 dose given at PTV-a will be 56 Gy/28 fractions level 1 60 Gy/30 fractions level 2 60.8 Gy/32 fractions level 3 Chemotherapy: temozolomide given at the dose of 75mg/m2
Outcomes
Primary Outcome Measures
To determine the OTR (optimal tolerated regimen) of radiotherapy administered in combination with temozolomide as first-line therapy in patients with de novo glioblastoma
Secondary Outcome Measures
Full Information
NCT ID
NCT01043536
First Posted
January 5, 2010
Last Updated
September 24, 2012
Sponsor
Centre Georges Francois Leclerc
Collaborators
Ligue contre le cancer, France
1. Study Identification
Unique Protocol Identification Number
NCT01043536
Brief Title
Dose Escalation Radiotherapy With Modulation of Intensity and Integrated Boost (SIB-IMRT) in the Treatment of Glioblastomas in Adults
Acronym
SIB-IMRT
Official Title
Dose Escalation Radiotherapy With Modulation of Intensity and Integrated Boost in Association With a Temozolomide in the Treatment of Glioblastoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Georges Francois Leclerc
Collaborators
Ligue contre le cancer, France
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The main goal of this study is to evaluate and to determine the dose of a highly accurate irradiation (allowing to increase the dose delivered while restricting the risk of complication) in association with temozolomide.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma
Keywords
IMRT, Radiotherapy escalation dose, glioblastoma, escalation radiotherapy dose
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
radiotherapy + temozolomide
Arm Type
Experimental
Arm Description
Radiotherapy:
dose given at PTV-g will be 70 Gy/28 fractions level 1 75 Gy/30 fractions level 2 80 Gy/32 fractions level 3
dose given at PTV-a will be 56 Gy/28 fractions level 1 60 Gy/30 fractions level 2 60.8 Gy/32 fractions level 3
Chemotherapy:
temozolomide given at the dose of 75mg/m2
Intervention Type
Radiation
Intervention Name(s)
radiotherapy
Intervention Description
patients will receive from 6 to 7 weeks 5 days a week radiations. The dose of radiation will depend on the level they will be included.
Intervention Type
Drug
Intervention Name(s)
temozolomide
Intervention Description
patient will receive whatever the level 7 days a week, temozolomide at the dose of 75mg/m2 during radiotherapy period. They will then follow one month after the end the radiochemotherapy an adjuvant treatment corresponding to a 5 days treatments of temozolomide at the dose of 200mg/m2 every 28 days.
Primary Outcome Measure Information:
Title
To determine the OTR (optimal tolerated regimen) of radiotherapy administered in combination with temozolomide as first-line therapy in patients with de novo glioblastoma
Time Frame
3 months after the start of the radiotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histopathologically proven diagnosis of glioblastoma (WHO grade IV astrocytoma)
Diagnosis must be obtained by a stereotactic or surgical biopsy
Age between 18 and 70
Total or partial surgical resection deemed as not possible by a neurosurgeon
OMS performance status 0 or 1
Adequate blood function : absolute neutrophil count > 1.5 x 109/L, platelets count > 100 x 109/L platelets;
Adequate liver function: bilirubin < 1.5 ULN (upper limit of normal), ALT and AST < 3 ULN,
Adequate renal function: creatinine < 1.5 ULN
Patient must have been informed and must have signed the specific informed consent form.
Exclusion Criteria:
other malignancy histology
resection of the brain tumor complete on MRI exploration
patient unable to give informed consent
patient presenting counter-indication to MRI exploration
patient must not have received neither radiotherapy nor chemotherapy for that affection
concomitant malignancy
patient already enrolled in another biomedical study with an experimental molecule
pregnant, nursing woman, or without contraception
private individuals of freedom or under tutelage (including legal guardianship)
psychiatric, behavioural disorders or geographical situation precluding the administration or follow-up of the protocol (including claustrophobia)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles Truc, MD
Organizational Affiliation
Centre Georges François Leclerc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Georges François Leclerc
City
Dijon
State/Province
Bourgogne
ZIP/Postal Code
21000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Dose Escalation Radiotherapy With Modulation of Intensity and Integrated Boost (SIB-IMRT) in the Treatment of Glioblastomas in Adults
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