Primary Brain TumorPhase 3NCT00430911
Radiotherapy for Malignant Astrocytomas in the Elderly
A Phase 3 study testing Radiotherapy in people with Primary Brain Tumor and Anaplastic Astrocytoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
A randomized trial comparing radiotherapy with supportive care in patients aged 70 years or older with newly diagnosed, histologically confirmed anaplastic astrocytoma or glioblastoma, and a Karnofsky performance status > 70. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Primary Brain Tumor, Anaplastic Astrocytoma, Glioblastoma Multiforme
- What is being tested?
- Radiotherapy
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- Feb 2001to not given
- Phase
- Phase 3
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Glioblastoma and anaplastic astrocytoma, supratentorial, histologically confirmed
- Brain CT scan or MRI within 28 days before surgery
- Age: 70 years or older
- Karnofsky performance status, 70 or more.
- Life expectancy over 12 weeks
- Informed consent
Who cannot join
- Brain radiotherapy
- Chemotherapy
- Severe systemic disease
Trial locations and contacts
1 site in 1 country.
About this study
A randomized trial comparing radiotherapy with supportive care in patients aged 70 years or older with newly diagnosed, histologically confirmed anaplastic astrocytoma or glioblastoma, and a Karnofsky performance status > 70.
- Being tested
- Radiotherapy
- Keywords
- malignant gliomas
- Medical subject headings
- Brain Neoplasms, Astrocytoma, Glioblastoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Secondary outcomes (3)
Progression free survival
Quality of life
Cognitive functions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2007 (estimated)
- Study startFeb 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Brain TumorStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- jean-yves Delattre, MD, Principal investigator, Assistance Publique - Hôpitaux de ParisFlorence Keime-Guibert, MD, Principal investigator, Assitance Publique-Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430911
- Sponsor's protocol ID
- PHRC, P000502 AOM 98071
- Status last verified
- Jan 2007
- First submitted
- 31 Jan 2007
- Last updated
- 2 Feb 2007
- Results posted
- No
Publications
Keime-Guibert F, Chinot O, Taillandier L, Cartalat-Carel S, Frenay M, Kantor G, Guillamo JS, Jadaud E, Colin P, Bondiau PY, Menei P, Loiseau H, Bernier V, Honnorat J, Barrie M, Mokhtari K, Mazeron JJ, Bissery A, Delattre JY; Association of French-Speaking Neuro-Oncologists. Radiotherapy for glioblastoma in the elderly. N Engl J Med. 2007 Apr 12;356(15):1527-35. doi: 10.1056/NEJMoa065901.
PubMed 17429084
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiotherapy for Malignant Astrocytomas in the Elderly
- ClinicalTrials.gov ID
- NCT00430911
- Acronym / sponsor ID
- PHRC, P000502 AOM 98071
- Keywords
- malignant gliomas
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2001
- First posted
- 2 Feb 2007 (estimated)
- 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.
A randomized trial comparing radiotherapy with supportive care in patients aged 70 years or older with newly diagnosed, histologically confirmed anaplastic astrocytoma or glioblastoma, and a Karnofsky performance status > 70.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Glioblastoma and anaplastic astrocytoma, supratentorial, histologically confirmed
- Brain CT scan or MRI within 28 days before surgery
- Age: 70 years or older
- Karnofsky performance status, 70 or more.
- Life expectancy over 12 weeks
Key exclusion criteria (3 listed)
- Brain radiotherapy
- Chemotherapy
- Severe systemic disease
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 |
|---|---|---|
| Radiotherapy | Drug | – |
Primary outcome
Survival
3 secondary outcomes
Progression free survival
Quality of life
Cognitive functions
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 2 Feb 2007.
- Derived from this study: PubMed 17429084Keime-Guibert F, Chinot O, Taillandier L, Cartalat-Carel S, Frenay M, Kantor G, Guillamo JS, Jadaud E, Colin P, Bondiau PY, Menei P, Loiseau H, Bernier V, Honnorat J, Barrie M, Mokhtari K, Mazeron JJ, Bissery A, Delattre JY; Association of French-Speaking Neuro-Oncologists. Radiotherapy for glioblastoma in the elderly. N Engl J Med. 2007 Apr 12;356(15):1527-35. doi: 10.1056/NEJMoa065901.
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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.
jean-yves Delattre, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Florence Keime-Guibert, MD principal investigator
Assitance Publique-Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radiotherapy in people with Primary Brain Tumor and Anaplastic Astrocytoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in 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 6 inclusion and 3 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 2 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00430911, which also lists 1 linked publication.
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 2 Feb 2007.