Dose Escalation Radiotherapy With Modulation of Intensity and Integrated Boost (SIB-IMRT) in the Treatment of Glioblastomas in Adults
This study has been completed.
Sponsor:
Centre Georges Francois Leclerc
Collaborator:
Ligue contre le cancer, France
Information provided by (Responsible Party):
Centre Georges Francois Leclerc
ClinicalTrials.gov Identifier:
NCT01043536
First received: January 5, 2010
Last updated: September 24, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Glioblastoma |
Radiation: radiotherapy Drug: temozolomide |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Dose Escalation Radiotherapy With Modulation of Intensity and Integrated Boost in Association With a Temozolomide in the Treatment of Glioblastoma |
Resource links provided by NLM:
Further study details as provided by Centre Georges Francois Leclerc:
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 [ Time Frame: 3 months after the start of the radiotherapy ] [ Designated as safety issue: Yes ]
| Enrollment: | 10 |
| Study Start Date: | September 2009 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: radiotherapy + temozolomide
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 |
Radiation: radiotherapy
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.
Drug: temozolomide
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01043536
Locations
| France | |
| Centre Georges François Leclerc | |
| Dijon, Bourgogne, France, 21000 | |
Sponsors and Collaborators
Centre Georges Francois Leclerc
Ligue contre le cancer, France
Investigators
| Principal Investigator: | Gilles Truc, MD | Centre Georges François Leclerc |
More Information
No publications provided
| Responsible Party: | Centre Georges Francois Leclerc |
| ClinicalTrials.gov Identifier: | NCT01043536 History of Changes |
| Other Study ID Numbers: | 0244-1blni08 / 009.020 |
| Study First Received: | January 5, 2010 |
| Last Updated: | September 24, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Centre Georges Francois Leclerc:
|
IMRT Radiotherapy escalation dose glioblastoma escalation radiotherapy dose |
Additional relevant MeSH terms:
|
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Temozolomide Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013