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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Institut Claudius Regaud
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud
ClinicalTrials.gov Identifier:
NCT01507506
First received: December 20, 2011
Last updated: September 5, 2014
Last verified: September 2014
  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).

Condition Intervention Phase
Glioblastoma
Radiation: Radiotherapy
Radiation: Experimental arm
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Institut Claudius Regaud:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival, defined as the time from randomization to the date of progression or death [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • Safety evaluated according to the classification of NCI CTCAE (Common Terminology Criteria for Adverse Events)V3.0 [ Time Frame: 8 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 220
Study Start Date: March 2011
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01507506

Contacts
Contact: Anne LAPRIE, Md 5 61 42 41 53 ext +33 laprie.anne@claudiusregaud.fr

Locations
France
Clinique Claude Bernard Recruiting
Albi, France, 81000
Contact: Pierre AUBERDIAC, MD    08 26 20 32 03 ext +33      
Principal Investigator: Pierre AUBERDIAC, MD         
Centre Jean Perrin Recruiting
Clermont-ferrand, France, 63011
Contact: Pierre VERRELLE, Pr    0473278142 ext +33    pierre.verrelle@cip.fr   
Principal Investigator: Pierre VERRELLE, Pr         
Sub-Investigator: Xavier DURANDO, Md         
Centre Georges François Leclerc Recruiting
Dijon, France, 21000
Contact: Gilles TRUC, Pr.         
Principal Investigator: Gilles TRUC, Pr.         
Centre Leon Berard Recruiting
Lyon, France, 69373
Contact: Marie-Pierre SUNYACH, Md    0478782828 ext +33    sunyach@lyon.fnclcc.fr   
Principal Investigator: Marie-Pierre SUNYACH, Md         
Sub-Investigator: Didier FRAPPAZ, Md         
Hospices Civils de Lyon (Hôpital Lyon Sud/Hôpital P. Wertheimer) Recruiting
Lyon, France, 69002
Contact: Anne D'HOMBRES, Md.    04 78 86 42 60 ext +33      
Principal Investigator: Anne D'HOMBRES, Md         
AP HM - Hôpital La Timone Recruiting
Marseille, France, 13385
Contact: Laetitia PADOVANI, Md    0491384334 ext +33    laetitia.padovani@ap-hm.fr   
Principal Investigator: laetitia PADOVANI, Md         
Centre Val d'Aurelle Recruiting
Montpellier, France, 34298
Contact: Christine KERR, Md    0467613132 ext +33    ckerr@valdorel.fnclcc.fr   
Principal Investigator: Christine KERR, Md         
Sub-Investigator: Michel FABBRO, md         
Sub-Investigator: Alain BONAFE, pr         
CHU de Strasbourg Recruiting
Strasbourg, France, 67065
Contact: Izzie-Jacques NAMER, Pr.    03 88 12 75 50 ext +33      
Principal Investigator: Izzie-Jacques NAMER, Pr.         
Centre Paul Strauss Recruiting
Strasbourg, France, 67065
Contact: Georges NOEL, Pr    0388252456 ext +33    gnoel@strasbourg.fnclcc.fr   
Principal Investigator: Georges NOEL, Pr         
Sub-Investigator: Roland SCHOTT, Md         
Sub-Investigator: Izzie jacques NAMMER, Pr         
Institut Claudius REGAUD Recruiting
Toulouse, France, 31052
Contact: Anne LAPRIE, m    561424153 ext +33    laprie.anne@claudiusregaud.fr   
Principal Investigator: Anne LAPRIE, Md         
Sub-Investigator: Elisabeth MOYAL, Pr         
Sub-Investigator: Henri ROCHE, Pr         
Sub-Investigator: Martine DELANNES, Md         
Sub-Investigator: Ewa Anna COTTURA, Md         
Sponsors and Collaborators
Institut Claudius Regaud
  More Information

No publications provided

Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT01507506     History of Changes
Other Study ID Numbers: 08 TETE 01
Study First Received: December 20, 2011
Last Updated: September 5, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Claudius Regaud:
Glioblastoma
Radiotherapy
Intensity modulated radiation therapy (IMRT)
Magnetic resonance spectroscopic imaging (MRSI)

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
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014