Back to results

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

Primary Purpose

Glioblastoma Multiforme

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Ultrafractionated brain irradiation

Temozolomide

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ultrafractionated brain irradiation - temozolomide

Arm Description

Outcomes

Primary Outcome Measures

complete response

defined as total regression of tumor area contrast in MRI, with stability or amelioration of neurological status of patient without corticoids

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

stabilization

corresponding to at least 50% diminution of tumor size in MRI, with stability of neurological status of patient receiving steady corticoid doses

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

Secondary Outcome Measures

global survival

treatment tolerance

evaluated by general, neurological and hematological status, according to National Cancer Institute-Common toxicity criteria (NCI-CTC)

survival without tumor recurrence

tumor recurrence detected with radiology examination

life quality

evaluated with European Organization for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ - C30)

Full Information

NCT ID

NCT03310372

First Posted

October 11, 2017

Last Updated

October 16, 2017

Sponsor

Central Hospital, Nancy, France

1. Study Identification

Unique Protocol Identification Number

NCT03310372

Brief Title

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

Acronym

TEMOFRAC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

February 13, 2008 (Actual)

Primary Completion Date

June 26, 2012 (Actual)

Study Completion Date

June 26, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma Multiforme

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ultrafractionated brain irradiation - temozolomide

Arm Type

Experimental

Intervention Type

Radiation

Intervention Name(s)

Ultrafractionated brain irradiation

Intervention Description

0.75 Gy a day, 5 times a week, for 6 weeks (total dose: 67.5 Gy)

Intervention Type

Drug

Intervention Name(s)

Temozolomide

Other Intervention Name(s)

Temodal

Intervention Description

75 mg/m2/day, 7 times a week, for 6 weeks (total 42 days)

Primary Outcome Measure Information:

Title

complete response

Description

defined as total regression of tumor area contrast in MRI, with stability or amelioration of neurological status of patient without corticoids

Time Frame