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Phase III Study Comparing 2 Brain Conformational Radiotherapy in Combination With Chemotherapy in the Treatment of Glioblastoma

Study Purpose

This is a multi-institutional phase III clinical study of interventional type. The trial will include 220 patients with confirmed unifocal glioblastoma over a period of 3 years + 3 years of follow up. Patients with unifocal glioblastoma (diagnosis confirmed by histology on tumoral biopsy or surgical specimen) and who meet all eligibility criteria will be randomized in one chemoradiotherapy arm :

  • - Conventional arm: 3-dimensional conformational radiotherapy + Temozolomide.
  • - Experimental arm : simultaneous-integrated boost with intensity-modulated radiotherapy guided by magnetic resonance spectroscopic imaging + Temozolomide The patient monitoring will be regular and standardized.
The main objective of this study is to improve overall survival of patients treated in experimental group (with simultaneous integrated boost).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patients must have unifocal glioblastoma (grade IV astrocytoma, WHO classification). The GBM can be:
  • - Or resectable and the patient has received curative surgery.
  • - Or unresectable, and the largest tumor diameter (contrast enhancement) must be less than 5 cm on MRI.
2. In all cases, the diagnosis must be confirmed by a pathologist. In patients for whom surgery is not possible, the diagnosis is confirmed by a biopsy of tumor tissue. 3. Methylation status of MGMT gene promoter is known. 4. Patients who have undergone resection should have received an MRI or a scan after surgery in order to visualize residual tumor. If not, the operative report must be available. 5. Surgery or biopsy must have occurred 45 days before the start of radiotherapy. 6. WHO ≤ 2. 7. Age ≥ 18 years. 8. Signed Consent collected before any specific procedure in the study. 9. Patient member in a national insurance scheme.

Exclusion Criteria:

1. Signs of hemorrhage on pre-radiotherapy MRI preventing a good spectrometric analysis. 2. Patient with multifocal glioblastoma. 3. Tumor located within 2 cm of the optic chiasm. 4. Patient with leptomeningeal metastases, 5. patients prone to epileptic seizures despite treatment with anticonvulsant. 6. Patients who received other previous treatment for glioblastoma multiforme. 7. Abnormal haematological results at inclusion with:
  • - Neutrophils < 1500/mm3.
  • - Blood-platelets < 100000/mm3.
8. Severe or chronic renal insufficiency (creatinin clearance ≤ 30 ml/min calculated using Cockroft-Gault's formula. 9. Patient unable to follow procedures, visits, examinations described in the study. 10. Any usual formal indication against imaging examinations (important claustrophobia, pace maker ...) 11. Pregnant women or nursing mothers can not participate in the study. Women of childbearing age must have a negative pregnancy test within 72 hours prior to study entry. 12. Men and women of childbearing age must use effective contraception at study entry and throughout the study. 13. Any concomitant or previous malignant disease within 5 years prior to study entry. 14. Any prior systemic chemotherapy within 5 years prior to inclusion (for malignant disease in medical history) 15. Any other medical conditions making the inclusion of the patient in the study inappropriate in the opinion of the investigator. 16. Patient under legal guardianship

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01507506
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Institut Claudius Regaud
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Terminated
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma
Arms & Interventions

Arms

Active Comparator: Conventional arm

3-dimensional conformal radiotherapy + Temozolomide

Experimental: Experimental arm

simultaneous-integrated boost with intensity-modulated radiotherapy guided by magnetic resonance spectroscopic imaging + Temozolomide

Interventions

Radiation: - Radiotherapy

Conventional arm: 3D conformational radiotherapy (arm A): 60 Gy per fractions of 2 Gy in 30 sessions on the PTV1 (contrast enhancement + 2 cm) with a linear accelerator equipped with a portal imaging. - Chemotherapy (Drug) :treatment should be combined with temozolomide during and after radiotherapy in a conventional treatment Stupp (Stupp et al. 2005), ie : - during radiotherapy : Temozolomide 75 mg/m2/day by oral route every day, - post radiotherapy : 6 cycles of Temozolomide oral route : 150 mg/m2/day from D1 to D5 for the 1st cycle followed by 200 mg/m2/day from D28 to D32.

Radiation: - Experimental arm

Conformational radiotherapy with simultaneous integrated boost by intensity modulation (Arm B): 60 Gy per fraction of 2 Gy in 30 sessions on the PTV1 (contrast enhancement + 2 cm) with concomitant daily superimposed boost on spectroscopic active region (PTV2) corresponding to the ratio Cho / NAA> 2 + 0.7 mm + contrast enhancement + 3mm. The PTV2 will receive a daily dose of 2.4 Gy for a cumulative dose of 72 Gy Only irradiation with simultaneous integrated boost are allowed - Chemotherapy (Drug) :treatment should be combined with temozolomide during and after radiotherapy in a conventional treatment Stupp (Stupp et al. 2005), ie : - during radiotherapy : Temozolomide 75 mg/m2/day by oral route every day, - post radiotherapy : 6 cycles of Temozolomide oral route : 150 mg/m2/day from D1 to D5 for the 1st cycle followed by 200 mg/m2/day from D28 to D32.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Clinique Claude Bernard, Albi, France

Status

Address

Clinique Claude Bernard

Albi, , 81000

Centre Jean Perrin, Clermont-ferrand, France

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Address

Centre Jean Perrin

Clermont-ferrand, , 63011

Centre Georges François Leclerc, Dijon, France

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Address

Centre Georges François Leclerc

Dijon, , 21000

Lyon, France

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Address

Hospices Civils de Lyon (Hôpital Lyon Sud/Hôpital P. Wertheimer)

Lyon, , 69002

Centre Leon Berard, Lyon, France

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Address

Centre Leon Berard

Lyon, , 69373

AP HM - Hôpital La Timone, Marseille, France

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Address

AP HM - Hôpital La Timone

Marseille, , 13385

Centre Val d'Aurelle, Montpellier, France

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Address

Centre Val d'Aurelle

Montpellier, , 34298

Institut de Cancerologie Lucien Neuwirth, Saint-Priest-En-Jarez, France

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Address

Institut de Cancerologie Lucien Neuwirth

Saint-Priest-En-Jarez, , 42271

Centre Paul Strauss, Strasbourg, France

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Address

Centre Paul Strauss

Strasbourg, , 67065

CHU de Strasbourg, Strasbourg, France

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Address

CHU de Strasbourg

Strasbourg, , 67065

Institut Claudius REGAUD, Toulouse, France

Status

Address

Institut Claudius REGAUD

Toulouse, , 31052

Centre Marie Curie, Valence, France

Status

Address

Centre Marie Curie

Valence, , 26953