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Concomitant Association of Ultrafractionated Brain Irradiation - Temozolomide in Inoperable Primary Glioblastoma Multiforme (TEMOFRAC)

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: NCT03310372
Recruitment Status : Completed
First Posted : October 16, 2017
Last Update Posted : October 17, 2017
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Study Description
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Brief Summary:

The main purpose of this study is the evaluation of concomitant association of ultrafractionated irradiation and Temodal® in patients with inoperable primary glioblastoma multiforme; study of tolerance and objective response rate.

The secondary purposes of this study are the evaluation of progression free survival, global survival and tolerance through toxicity study. The therapeutic response according to methylation or not of MGMT is also evaluated.


Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Radiation: Ultrafractionated brain irradiation Drug: Temozolomide Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Clinical Trial of Concomitant Association of Ultrafractionated Brain Irradiation - Temozolomide in Inoperable Primary Glioblastoma Multiforme
Actual Study Start Date : February 13, 2008
Actual Primary Completion Date : June 26, 2012
Actual Study Completion Date : June 26, 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: ultrafractionated brain irradiation - temozolomide Radiation: Ultrafractionated brain irradiation
0.75 Gy a day, 5 times a week, for 6 weeks (total dose: 67.5 Gy)

Drug: Temozolomide
75 mg/m2/day, 7 times a week, for 6 weeks (total 42 days)
Other Name: Temodal


Outcome Measures
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Primary Outcome Measures :
  1. complete response [ Time Frame: through study completion, 2 years ]
    defined as total regression of tumor area contrast in MRI, with stability or amelioration of neurological status of patient without corticoids

  2. partial response [ Time Frame: through study completion, 2 years ]
    defined by at least 50% diminution of tumor size, evaluated by the product of 2 perpendicular diameters measured by MRI, with stability or amelioration of neurological status of patient receiving stable or reduced corticoid doses

  3. stabilization [ Time Frame: through study completion, 2 years ]
    corresponding to at least 50% diminution of tumor size in MRI, with stability of neurological status of patient receiving steady corticoid doses

  4. progression [ Time Frame: through study completion, 2 years ]
    defined by increase of at least 25% of tumor size and/or a second brain localization in MRI, with degradation of neurological status of patient


Secondary Outcome Measures :
  1. global survival [ Time Frame: through study completion, 2 years ]
  2. treatment tolerance [ Time Frame: through study completion, 2 years ]
    evaluated by general, neurological and hematological status, according to National Cancer Institute-Common toxicity criteria (NCI-CTC)

  3. survival without tumor recurrence [ Time Frame: through study completion, 2 years ]
    tumor recurrence detected with radiology examination

  4. life quality [ Time Frame: through study completion, 2 years ]
    evaluated with European Organization for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ - C30)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • giving their informed consent
  • having a supratentorial malignant glioma, either grade 4 of St. Anne/Mayo grading, or glioblastoma multiforme according to WHO classification
  • having an inoperable brain tumor (diagnosed by stereotactic biopsy)
  • having a general status, evaluated by Karnofsky scale, >60
  • having a life expectancy >3 months
  • not having previously had a brain irradiation and/or adjuvant or neo-adjuvant chemotherapy
  • potentially having another cancer, if histology and clinical history are available for comparison
  • being able to take oral tablets
  • no HIV disease
  • satisfactory hematology, hepatic and renal functions: polymorphonuclear neutrophils >1500/mm3, platelets >100000/mm3, Hb >8g/dl, creatinemia ≤1.5 times upper normal value, total bilirubin <1.5 times upper normal value, ASAT and ALAT <3 times upper normal value
  • for women of childbearing potential, a contraception is given

Exclusion Criteria:

  • having an under tentorial malignant glioma (brain stem and/or cerebellum), grade 4 of St. Anne/Mayo grading
  • having a Karnofsky score <60
  • having a life expectancy <3 months
  • having had a brain irradiation or an adjuvant or neoadjuvant chemotherapy
  • refusing any additional therapy
  • having a non-malignant but serious systemic disease or uncontrolled active infection
  • having a severe psychiatric disorder
  • not having signed the informed consent
  • pregnant or breastfeeding woman
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03310372    
Other Study ID Numbers: 2007-004968-41
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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