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

Phase II Clinical Trial of Concomitant Association of Ultrafractionated Brain Irradiation - Temozolomide in Inoperable Primary Glioblastoma Multiforme

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.

Study Overview

• Status: Completed
• Conditions: Glioblastoma Multiforme
• Intervention / Treatment: Radiation: Ultrafractionated brain irradiation; Drug: Temozolomide

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Temodal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complete response	defined as total regression of tumor area contrast in MRI, with stability or amelioration of neurological status of patient without corticoids	through study completion, 2 years
partial response	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	through study completion, 2 years
stabilization	corresponding to at least 50% diminution of tumor size in MRI, with stability of neurological status of patient receiving steady corticoid doses	through study completion, 2 years
progression	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	through study completion, 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
global survival		through study completion, 2 years
treatment tolerance	evaluated by general, neurological and hematological status, according to National Cancer Institute-Common toxicity criteria (NCI-CTC)	through study completion, 2 years
survival without tumor recurrence	tumor recurrence detected with radiology examination	through study completion, 2 years
life quality	evaluated with European Organization for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ - C30)	through study completion, 2 years

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2008
• Primary Completion (Actual): June 26, 2012
• Study Completion (Actual): June 26, 2012

Study Registration Dates

• First Submitted: October 11, 2017
• First Submitted That Met QC Criteria: October 11, 2017
• First Posted (Actual): October 16, 2017

Study Record Updates

• Last Update Posted (Actual): October 17, 2017
• Last Update Submitted That Met QC Criteria: October 16, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Temozolomide
• Other Study ID Numbers: 2007-004968-41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No