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Completed

NCT Number: NCT03310372

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.

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Key information

Conditions

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

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrafractionated brain irradiation

Radiation

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

Temozolomide

Drug

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

Other names: Temodal

Primary outcomes

  1. complete response

    Time frame: through study completion, 2 years

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

  2. partial response

    Time frame: through study completion, 2 years

    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

  3. stabilization

    Time frame: through study completion, 2 years

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

  4. progression

    Time frame: through study completion, 2 years

    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 outcomes

  1. global survival

    Time frame: through study completion, 2 years

  2. treatment tolerance

    Time frame: through study completion, 2 years

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

  3. survival without tumor recurrence

    Time frame: through study completion, 2 years

    tumor recurrence detected with radiology examination

  4. life quality

    Time frame: through study completion, 2 years

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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: TEMOFRAC

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Oct 16, 2017
Registry last updated
Oct 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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