Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

Tracking Information
First Submitted Date  ICMJE October 11, 2017
First Posted Date  ICMJE October 16, 2017
Last Update Posted Date October 17, 2017
Actual Study Start Date  ICMJE February 13, 2008
Actual Primary Completion Date June 26, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2017)
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03310372 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2017)
  • global survival [ Time Frame: through study completion, 2 years ]
  • 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)
  • survival without tumor recurrence [ Time Frame: through study completion, 2 years ]
    tumor recurrence detected with radiology examination
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2017)
  • global survival [ Time Frame: through study completion, 2 years ]
  • treatment tolerance [ Time Frame: through study completion, 2 years ]
    evaluated by general, neurological and hematological status, according to toxicity scale used by National Cancer Institute
  • survival without tumor recurrence [ Time Frame: through study completion, 2 years ]
    tumor recurrence detected with radiology examination
  • life quality [ Time Frame: through study completion, 2 years ]
    evaluated with EORTC QLQ - C30 questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Concomitant Association of Ultrafractionated Brain Irradiation - Temozolomide in Inoperable Primary Glioblastoma Multiforme
Official Title  ICMJE Phase II Clinical Trial of Concomitant Association of Ultrafractionated Brain Irradiation - Temozolomide in Inoperable Primary Glioblastoma Multiforme
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma Multiforme
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: ultrafractionated brain irradiation - temozolomide
Interventions:
  • Radiation: Ultrafractionated brain irradiation
  • Drug: Temozolomide
Publications * Not Provided

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: October 11, 2017)
46
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 26, 2012
Actual Primary Completion Date June 26, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 74 Years   (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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03310372
Other Study ID Numbers  ICMJE 2007-004968-41
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Central Hospital, Nancy, France
Study Sponsor  ICMJE Central Hospital, Nancy, France
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Central Hospital, Nancy, France
Verification Date October 2017

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