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

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ClinicalTrials.gov Identifier: NCT01507506
Recruitment Status : Terminated
First Posted : January 11, 2012
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud

Tracking Information
First Submitted Date  ICMJE December 20, 2011
First Posted Date  ICMJE January 11, 2012
Last Update Posted Date January 12, 2021
Actual Study Start Date  ICMJE March 15, 2011
Actual Primary Completion Date January 2, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2012)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2012)
  • Progression-free survival, defined as the time from randomization to the date of progression or death [ Time Frame: 8 years ]
  • Safety evaluated according to the classification of NCI CTCAE (Common Terminology Criteria for Adverse Events)V3.0 [ Time Frame: 8 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase III Study Comparing 2 Brain Conformational Radiotherapy in Combination With Chemotherapy in the Treatment of Glioblastoma
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Conventional arm
    3-dimensional conformal radiotherapy + Temozolomide
    Intervention: Radiation: Radiotherapy
  • Experimental: Experimental arm
    simultaneous-integrated boost with intensity-modulated radiotherapy guided by magnetic resonance spectroscopic imaging + Temozolomide
    Intervention: Radiation: Experimental arm
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 28, 2018)
180
Original Estimated Enrollment  ICMJE
 (submitted: January 10, 2012)
220
Actual Study Completion Date  ICMJE January 2, 2020
Actual Primary Completion Date January 2, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01507506
Other Study ID Numbers  ICMJE 08 TETE 01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut Claudius Regaud
Study Sponsor  ICMJE Institut Claudius Regaud
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Institut Claudius Regaud
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP