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

Glioblastoma Multiforme Clinical Trial

— TEMOFRAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03310372
• Other study ID #: 2007-004968-41
• Status: Completed
• Phase: Phase 2
• First received: October 11, 2017
• Last updated: October 16, 2017
• Start date: February 13, 2008
• Est. completion date: June 26, 2012

Study information

• Verified date: October 2017
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 26, 2012
• Est. primary completion date: June 26, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	global survival		through study completion, 2 years
Secondary	treatment tolerance	evaluated by general, neurological and hematological status, according to National Cancer Institute-Common toxicity criteria (NCI-CTC)	through study completion, 2 years
Secondary	survival without tumor recurrence	tumor recurrence detected with radiology examination	through study completion, 2 years
Secondary	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