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

NCT03310372 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2017-10-17

No results posted yet for this study

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.

Conditions

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)

Sponsors & Collaborators

  • Central Hospital, Nancy, France

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-13
Primary Completion
2012-06-26
Completion
2012-06-26

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03310372 on ClinicalTrials.gov