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

NCT03310372 | Completed Phase 2 DMC

• 1 other identifier: 2007-004968-41
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• global survival

  through study completion, 2 years

• treatment tolerance

  through study completion, 2 years

• survival without tumor recurrence

  through study completion, 2 years

• life quality

  through study completion, 2 years

Study Arms (1)

ultrafractionated brain irradiation - temozolomide

EXPERIMENTAL

Radiation: Ultrafractionated brain irradiation; Drug: Temozolomide

Interventions

Ultrafractionated brain irradiation RADIATION

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

ultrafractionated brain irradiation - temozolomide

Temozolomide DRUG

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

Also known as: Temodal

ultrafractionated brain irradiation - temozolomide

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

MeSH Terms

Conditions

Glioblastoma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: October 16, 2017
• Study Start: February 13, 2008
• Primary Completion: June 26, 2012
• Study Completion: June 26, 2012
• Last Updated: October 17, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share