Brain and Central Nervous System TumorsPhase 3NCT00820963
Standard Radiation Therapy, Higher-Dose Radiation Therapy, or Chemotherapy in Treating Older Patients With Glioblastoma Multiforme
A Phase 3 study testing temozolomide, hypofractionated radiation therapy and radiation therapy in people with Brain and Central Nervous System Tumors, run by Centre Leon Berard at 1 site in France.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in higher doses over a shorter period of time may kill more tumor cells and have fewer side effects. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- temozolomide, hypofractionated radiation therapy and radiation therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2006to May 2011
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed glioblastoma multiforme
- Grade 4 disease (WHO)
PATIENT CHARACTERISTICS:
- WHO performance status (PS) 0-2 (PS 3-4 allowed if secondary to a neurological physical handicap)
- Life expectancy ≥ 3 months
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10 g/dL
- Bilirubin < 1.5 times upper limit of normal (ULN)
- Transaminases ≤ 3 times ULN
- Creatinine < 1.5 times ULN
- Able to tolerate the 3 treatment options
- No other malignancy within the past 5 years except for curatively treated basal cell or squamous cell carcinoma of the skin
- No acute or chronic severe illness that, in the investigator's opinion, contraindicates participation in the study
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy, radiotherapy, or immunotherapy
- Concurrent corticosteroids allowed provided patient is receiving the lowest dose necessary for optimal functioning
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Study of Normal-fractionated Radiotherapy Versus Hypofractionated Radiotherapy Versus Chemotherapy in Patients Over 60 Years With Malignant Glioma
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in higher doses over a shorter period of time may kill more tumor cells and have fewer side effects. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether standard radiation therapy, higher-dose radiation therapy, or chemotherapy is more effective in treating older patients with glioblastoma multiforme.
PURPOSE: This randomized phase III trial is studying standard radiation therapy to see how well it works compared with higher-dose radiation therapy or chemotherapy in treating older patients with glioblastoma multiforme.
Read the detailed description
OBJECTIVES:
Primary
- Compare the survival of patients over 60 with glioblastoma multiforme treated with standard radiotherapy vs hypofractionated radiotherapy vs chemotherapy.
Secondary
- Compare the quality of life (QLQ-C30) of these patients.
- Compare the safety, tolerance, and toxicity of these regimens.
- Assess the pharmacoeconomic cost of these regimens.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients undergo standard radiotherapy 5 days a week for 6 weeks.
- Arm II: Patients undergo hypofractionated radiotherapy 5 days a week for 2 weeks.
- Arm III: Patients receive oral temozolomide on days 1-5. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- temozolomide, hypofractionated radiation therapy, radiation therapy
- Keywords
- adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma
- Medical subject headings
- Central Nervous System Neoplasms, Glioblastoma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temozolomideDrug
Given orally
hypofractionated radiation therapyRadiation
Patients undergo hypofractionated radiotherapy
radiation therapyRadiation
Patients undergo standard radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients undergo standard radiotherapy 5 days a week for 6 weeks. Receives: Radiation: radiation therapy |
| Arm II | Experimental | Patients undergo hypofractionated radiotherapy 5 days a week for 2 weeks. Receives: Radiation: hypofractionated radiation therapy |
| Arm III | Experimental | Patients receive oral temozolomide on days 1-5. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2009 (estimated)
- Study startJul 2006
- Primary completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe 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
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Investigators
- Didier Frappaz, MD, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820963
- Sponsor's protocol ID
- CDR0000626713
- Other IDs
- LEONB-ET2005-006, LEONB-Nordic Glioma Adulte, INCA-RECF0031, EUDRACT-2006-003606-25, SPRI-LEONB-ET2005-006
- Status last verified
- Jul 2009
- First submitted
- 9 Jan 2009
- Last updated
- 12 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Normal-fractionated Radiotherapy Versus Hypofractionated Radiotherapy Versus Chemotherapy in Patients Over 60 Years With Malignant Glioma
- ClinicalTrials.gov ID
- NCT00820963
- Acronym / sponsor ID
- CDR0000626713
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- May 2011 (actual)
- First posted
- 12 Jan 2009 (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.
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in higher doses over a shorter period of time may kill more tumor cells and have fewer side effects. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether standard radiation therapy, higher-dose radiation therapy, or chemotherapy is more effective in treating older patients with glioblastoma multiforme.
PURPOSE: This randomized phase III trial is studying standard radiation therapy to see how well it works compared with higher-dose radiation therapy or chemotherapy in treating older patients with glioblastoma multiforme.
Detailed description
OBJECTIVES:
Primary
- Compare the survival of patients over 60 with glioblastoma multiforme treated with standard radiotherapy vs hypofractionated radiotherapy vs chemotherapy.
Secondary
- Compare the quality of life (QLQ-C30) of these patients.
- Compare the safety, tolerance, and toxicity of these regimens.
- Assess the pharmacoeconomic cost of these regimens.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients undergo standard radiotherapy 5 days a week for 6 weeks.
- Arm II: Patients undergo hypofractionated radiotherapy 5 days a week for 2 weeks.
- Arm III: Patients receive oral temozolomide on days 1-5. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Radiation: radiation therapyPatients undergo standard radiotherapy 5 days a week for 6 weeks. |
| Arm II | Experimental | Radiation: hypofractionated radiation therapyPatients undergo hypofractionated radiotherapy 5 days a week for 2 weeks. |
| Arm III | Experimental | Drug: temozolomidePatients receive oral temozolomide on days 1-5. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| temozolomideGiven orally | Drug | Arm III |
| hypofractionated radiation therapyPatients undergo hypofractionated radiotherapy | Radiation | Arm II |
| radiation therapyPatients undergo standard radiotherapy | Radiation | Arm I |
Primary outcome
Duration of survival
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 12 May 2011.
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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.
Didier Frappaz, MD
Centre Leon Berard
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 temozolomide, hypofractionated radiation therapy and radiation therapy in people with Brain and Central Nervous System Tumors, run by Centre Leon Berard 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?
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 12 May 2011. 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?
Duration of survival. 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 12 May 2011.