MeningiomaMARCIENCT01166321
Carbon Ion Radiotherapy for Atypical Meningiomas
A study testing Carbon Ion Radiotherapy in people with Meningioma, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
Treatment standard for patients with atypical or anaplastic meningioma is neurosurgical resection. With this approach, local control ranges between 50 and 70%, depending on resection status. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meningioma
- What is being tested?
- Carbon Ion Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2012to Feb 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically confirmed atypical meningioma
- macroscopic tumor after biopsy or subtotal resection
- Simpson Grade 4 or 5
- prior photon radiotherapy to the clinical target volume (CTV) of 48-52 Gy
- beginning of study treatment no later than 12 weeks after surgery
- age ≥ 18 years of age
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- Karnofsky Performance Score ≥ 60
- For women with childbearing potential, adequate contraception
- Ability of subject to understand character and individual consequences of the clinical trial
- Written informed consent (must be available before enrolment in the trial)
Who cannot join
- refusal of the patients to take part in the study
- previous radiotherapy of the brain
- optic nerve sheath meningioma (ONSM)
- time interval of > 12 weeks after primary diagnosis (neurosurgical intervention) and beginning of study treatment
- Patients who have not yet recovered from acute toxicities of prior therapies
- Known carcinoma < 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy
- Pregnant or lactating women
- Participation in another clinical study or observation period of competing trials, respectively
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Patients With Atypical Meningiomas Simpson Grade 4 and 5 With a Carbon Ion Boost in Combination With Postoperative Photon Radiotherapy: A Phase II Trial
Treatment standard for patients with atypical or anaplastic meningioma is neurosurgical resection. With this approach, local control ranges between 50 and 70%, depending on resection status. A series or smaller studies has shown that postoperative radiotherapy in this patient population can increase progression-free survival, which translates into increased overall survival. However, meningiomas are known to be radioresistant tumors, and radiation doses of 60 Gy or higher have been shown to be necessary for tumor control.
Carbon ions offer physical and biological characteristics. Due to their inverted dose profile and the high local dose deposition within the Bragg peak precise dose application and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an increased relative biological effectiveness (RBE), which can be calculated between 2 and 5 depending on the cell line as well as the endpoint analyzed.
Read more
First data obtained within the Phase I/II trial performed at GSI in Darmstadt on carbon ion radiotherapy for patients with high-risk meningiomas has shown safety, and treatment results are promising.
Therefore, in the current Phase II-MARCIE-Study a carbon ion boost will be applied to the macroscopic tumor (gross tumor volume, GTV) in conjunction with photon radiotherapy to the clinical target volume (CTV) in patients with atypical meningiomas after incomplete resection or biopsy.
Primary endpoint is progression-free survival rate, secondary endpoints are overall survival, safety and toxicity.
- Conditions
- Meningioma
- Being tested
- Carbon Ion Radiotherapy
- Keywords
- Atypical Meningioma
- Medical subject headings
- Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon Ion RadiotherapyRadiation
Carbon Ion Boost 18 Gy E in single Fractions of 3 Gy E
| Study group | Role | What they receive |
|---|---|---|
| Carbon Ion Radiotherapy Boost | Experimental | Carbon Ion Boost to the Macroscopic Tumor visible on contrast-enhanced MR-Imaging Receives: Radiation: Carbon Ion Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: Progression-free survival at 3 years
Secondary outcomes (1)
Overall Survival
Measured: Overall Survival at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2010 (estimated)
- Study startJun 2012
- Primary completionJul 2020
- Study completionFeb 2026 (estimated)
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 MeningiomaStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juergen Debus, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166321
- Sponsor's protocol ID
- MARCIE
- Other IDs
- 2009-016683-36, 2009
- Acronym
- MARCIE
- Status last verified
- Jan 2024
- First submitted
- 20 Jul 2010
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Combs SE, Edler L, Burkholder I, Rieken S, Habermehl D, Jakel O, Haberer T, Unterberg A, Wick W, Debus J, Haselmann R. Treatment of patients with atypical meningiomas Simpson grade 4 and 5 with a carbon ion boost in combination with postoperative photon radiotherapy: the MARCIE trial. BMC Cancer. 2010 Nov 9;10:615. doi: 10.1186/1471-2407-10-615.
PubMed 21062428
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Patients With Atypical Meningiomas Simpson Grade 4 and 5 With a Carbon Ion Boost in Combination With Postoperative Photon Radiotherapy: A Phase II Trial
- ClinicalTrials.gov ID
- NCT01166321
- Acronym / sponsor ID
- MARCIE / MARCIE
- Conditions
- Meningioma
- Keywords
- Atypical Meningioma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- Jun 2012 (actual)
- Primary completion
- Jul 2020 (actual)
- Study completion
- Feb 2026 (estimated)
- First posted
- 21 Jul 2010 (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.
Treatment standard for patients with atypical or anaplastic meningioma is neurosurgical resection. With this approach, local control ranges between 50 and 70%, depending on resection status. A series or smaller studies has shown that postoperative radiotherapy in this patient population can increase progression-free survival, which translates into increased overall survival. However, meningiomas are known to be radioresistant tumors, and radiation doses of 60 Gy or higher have been shown to be necessary for tumor control.
Carbon ions offer physical and biological characteristics. Due to their inverted dose profile and the high local dose deposition within the Bragg peak precise dose application and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an increased relative biological effectiveness (RBE), which can be calculated between 2 and 5 depending on the cell line as well as the endpoint analyzed.
First data obtained within the Phase I/II trial performed at GSI in Darmstadt on carbon ion radiotherapy for patients with high-risk meningiomas has shown safety, and treatment results are promising.
Therefore, in the current Phase II-MARCIE-Study a carbon ion boost will be applied to the macroscopic tumor (gross tumor volume, GTV) in conjunction with photon radiotherapy to the clinical target volume (CTV) in patients with atypical meningiomas after incomplete resection or biopsy.
Primary endpoint is progression-free survival rate, secondary endpoints are overall survival, safety and toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carbon Ion Radiotherapy Boost | Experimental | Radiation: Carbon Ion RadiotherapyCarbon Ion Boost to the Macroscopic Tumor visible on contrast-enhanced MR-Imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- histologically confirmed atypical meningioma
- macroscopic tumor after biopsy or subtotal resection
- Simpson Grade 4 or 5
- prior photon radiotherapy to the clinical target volume (CTV) of 48-52 Gy
- beginning of study treatment no later than 12 weeks after surgery
Key exclusion criteria (8 listed)
- refusal of the patients to take part in the study
- previous radiotherapy of the brain
- optic nerve sheath meningioma (ONSM)
- time interval of > 12 weeks after primary diagnosis (neurosurgical intervention) and beginning of study treatment
- Patients who have not yet recovered from acute toxicities of prior therapies
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 |
|---|---|---|
| Carbon Ion RadiotherapyCarbon Ion Boost 18 Gy E in single Fractions of 3 Gy E | Radiation | Carbon Ion Radiotherapy Boost |
Primary outcome
Progression-free survival
Time frame: Progression-free survival at 3 years
1 secondary outcome
Overall Survival
Time frame: Overall Survival at 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Derived from this study: PubMed 21062428Combs SE, Edler L, Burkholder I, Rieken S, Habermehl D, Jakel O, Haberer T, Unterberg A, Wick W, Debus J, Haselmann R. Treatment of patients with atypical meningiomas Simpson grade 4 and 5 with a carbon ion boost in combination with postoperative photon radiotherapy: the MARCIE trial. BMC Cancer. 2010 Nov 9;10:615. doi: 10.1186/1471-2407-10-615.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbon Ion Radiotherapy in people with Meningioma, run by University Hospital Heidelberg at 1 site in Germany.
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 10 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 5 Jan 2024. 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 Germany. 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.
Are results available for this study?
Results are not available in the source record.
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?
Progression-free survival (time frame: Progression-free survival at 3 years). 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 NCT01166321, 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 5 Jan 2024.