Glioblastoma MultiformePhase 2TEMOFRACNCT03310372
Concomitant Association of Ultrafractionated Brain Irradiation - Temozolomide in Inoperable Primary Glioblastoma Multiforme
A Phase 2 study testing Ultrafractionated brain irradiation and Temozolomide in people with Glioblastoma Multiforme, run by Central Hospital, Nancy, France.
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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- Ultrafractionated brain irradiation and Temozolomide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 13 Feb 2008to 26 Jun 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- having a severe psychiatric disorder
- not having signed the informed consent
- pregnant or breastfeeding woman
About this study
Official title: 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.
- Conditions
- Glioblastoma Multiforme
- Being tested
- Ultrafractionated brain irradiation, Temozolomide
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrafractionated brain irradiationRadiation
0.75 Gy a day, 5 times a week, for 6 weeks (total dose: 67.5 Gy)
TemozolomideDrug
Also called Temodal
75 mg/m2/day, 7 times a week, for 6 weeks (total 42 days)
| Study group | Role | What they receive |
|---|---|---|
| ultrafractionated brain irradiation - temozolomide | Experimental | Not described Receives: Radiation: Ultrafractionated brain irradiation; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response
defined as total regression of tumor area contrast in MRI, with stability or amelioration of neurological status of patient without corticoids
Measured: 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
Measured: 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
Measured: 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
Measured: through study completion, 2 years
Secondary outcomes (4)
global survival
Measured: through study completion, 2 years
treatment tolerance
evaluated by general, neurological and hematological status, according to National Cancer Institute-Common toxicity criteria (NCI-CTC)
Measured: through study completion, 2 years
survival without tumor recurrence
tumor recurrence detected with radiology examination
Measured: 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)
Measured: through study completion, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start13 Feb 2008
- Primary completion26 Jun 2012
- Study completion26 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310372
- Sponsor's protocol ID
- 2007-004968-41
- Acronym
- TEMOFRAC
- Status last verified
- Oct 2017
- First submitted
- 11 Oct 2017
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial of Concomitant Association of Ultrafractionated Brain Irradiation - Temozolomide in Inoperable Primary Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT03310372
- Acronym / sponsor ID
- TEMOFRAC / 2007-004968-41
- Conditions
- Glioblastoma Multiforme
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 13 Feb 2008 (actual)
- Primary completion
- 26 Jun 2012 (actual)
- Study completion
- 26 Jun 2012 (actual)
- First posted
- 16 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultrafractionated brain irradiation - temozolomide | Experimental | Radiation: Ultrafractionated brain irradiation, Drug: Temozolomide |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrafractionated brain irradiation0.75 Gy a day, 5 times a week, for 6 weeks (total dose: 67.5 Gy) | Radiation | ultrafractionated brain irradiation - temozolomide |
| TemozolomideAlso: Temodal75 mg/m2/day, 7 times a week, for 6 weeks (total 42 days) | Drug | ultrafractionated brain irradiation - temozolomide |
Primary outcome
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
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
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
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
4 secondary outcomes
global survival
Time frame: through study completion, 2 years
treatment tolerance
Time frame: through study completion, 2 years
survival without tumor recurrence
Time frame: through study completion, 2 years
life quality
Time frame: through study completion, 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ultrafractionated brain irradiation and Temozolomide in people with Glioblastoma Multiforme, run by Central Hospital, Nancy, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete response (time frame: through study completion, 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2017.