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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01507506
Recruitment Status : Active, not recruiting
First Posted : January 11, 2012
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud

Brief Summary:

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).

Condition or disease Intervention/treatment Phase
Glioblastoma Radiation: Radiotherapy Radiation: Experimental arm Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Randomized Study Comparing 2 Brain Conformational Radiotherapy in Combination With Chemotherapy in the Treatment of Glioblastoma : Standard 3D Conformational Radiotherapy Versus Intensity-modulated Radiotherapy With Simultaneous-integrated Boost Guided by Magnetic Resonance Spectroscopic Imaging
Actual Study Start Date : March 15, 2011
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Conventional arm
3-dimensional conformal radiotherapy + Temozolomide
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.

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




Primary Outcome Measures :
  1. Overall survival defined as the time from randomization to the date of death or date of last follow-up news (censured data) [ Time Frame: 8 years ]

Secondary Outcome Measures :
  1. Progression-free survival, defined as the time from randomization to the date of progression or death [ Time Frame: 8 years ]
  2. Safety evaluated according to the classification of NCI CTCAE (Common Terminology Criteria for Adverse Events)V3.0 [ Time Frame: 8 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01507506


Locations
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France
Clinique Claude Bernard
Albi, France, 81000
Centre Jean Perrin
Clermont-ferrand, France, 63011
Centre Georges François Leclerc
Dijon, France, 21000
Hospices Civils de Lyon (Hôpital Lyon Sud/Hôpital P. Wertheimer)
Lyon, France, 69002
Centre Leon Berard
Lyon, France, 69373
AP HM - Hôpital La Timone
Marseille, France, 13385
Centre Val d'Aurelle
Montpellier, France, 34298
Institut de Cancerologie Lucien Neuwirth
Saint-Priest-En-Jarez, France, 42271
Centre Paul Strauss
Strasbourg, France, 67065
CHU de Strasbourg
Strasbourg, France, 67065
Institut Claudius REGAUD
Toulouse, France, 31052
Centre Marie Curie
Valence, France, 26953
Sponsors and Collaborators
Institut Claudius Regaud

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT01507506    
Other Study ID Numbers: 08 TETE 01
First Posted: January 11, 2012    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Keywords provided by Institut Claudius Regaud:
Glioblastoma
Radiotherapy
Intensity modulated radiation therapy (IMRT)
Magnetic resonance spectroscopic imaging (MRSI)
Additional relevant MeSH terms:
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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
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents