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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-15

Study Completion Date

2020-01-02

Brief Summary

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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).

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Detailed Description

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Conditions

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Glioblastoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional arm

3-dimensional conformal radiotherapy + Temozolomide

Group Type ACTIVE_COMPARATOR

Radiotherapy

Intervention Type RADIATION

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.

Experimental arm

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

Group Type EXPERIMENTAL

Experimental arm

Intervention Type RADIATION

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.

Interventions

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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.

Intervention Type 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.

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No