cropped color_logo_with_background.png

Clinical Trial Finder

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 74 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03310372
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Central Hospital, Nancy, France
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma Multiforme
Arms & Interventions

Arms

Experimental: ultrafractionated brain irradiation - temozolomide

Interventions

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)

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

Powered By