Treatment of patients with atypical meningiomas Simpson Grade 4 and 5 with a carbon ion boost in combination with post-operative photon radiotherapy: MARCIE trial
| ISRCTN | ISRCTN58692836 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58692836 |
| EudraCT/CTIS number | 2009-016683-36 |
| ClinicalTrials.gov number | NCT01166321 |
| Secondary identifying numbers | EudraCT No.:2009-016683-36 |
- Submission date
- 10/07/2010
- Registration date
- 07/02/2011
- Last edited
- 15/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Meningiomas are tumours of the membranes that cover the brain. Meningiomas are described as atypical when the tumor cells do not appear typical or normal. The standard treatment for patients with atypical meningioma is surgery to remove the tumour. Radiotherapy to kill any tumour cells left behind after surgery (post-operative radiotherapy) can increase the patient survival rate. The aim of this study is to find out whether a form of radiotherapy called carbon ion boost in combination with post-operative photon radiotherapy can improve the patient survival rate after 3 years.
Who can participate?
Patients aged 18 or over with atypical meningioma
What does the study involve?
All participants are treated with carbon ion boost in combination with post-operative photon radiotherapy. Survival rate, safety and toxicity are assessed.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
University Hospital of Heidelberg (Germany)
When is the study starting and how long is it expected to run for?
September 2010 to August 2016
Who is funding the study?
University Hospital of Heidelberg (Germany)
Who is the main contact?
Prof. Juergen Debus
juergen.debus@med.uni-heidelberg.de
Contact information
Scientific
University Hospital of Heidelberg
Department of Radiation Oncology
Im Neuenheimer Feld 400
Heidelberg
69120
Germany
| Phone | +49 (0)6221 56 8201 |
|---|---|
| juergen.debus@med.uni-heidelberg.de |
Study information
| Study design | Single-arm phase II trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A phase II single-arm trial of the treatment of patients with atypical meningiomas Simpson Grade 4 and 5 with a carbon ion boost in combination with post-operative photon radiotherapy |
| Study acronym | MARCIE |
| Study objectives | The study is designed to demonstrate that carbon ion boost in combination with post-operative photon radiotherapy can improve the progression-free survival rate after 3 years by 20%. The benchmark for largest PFS-3yR which, if true, implies that the efficacy of study treatment is too low is assumed to be 50% according to literature data with a comparable patient population (patients with atypical meningiomas Simpson grade 4 and 5 and without previous radiotherapy). |
| Ethics approval(s) | Local medical ethics committee (Ethikkommission der Medizinischen Fakultät Heidelberg), 21/01/2010, ref: S444-2009 |
| Health condition(s) or problem(s) studied | Atypical meningioma |
| Intervention | No drugs are applied, only radiation therapy. There is only one treatment arm, consisting of photon radiotherapy up to 50 Gy, carbon ion boost to the macroscopic tumour up to a total dose of 18 Gy E in single doses of 3 Gy E. |
| Intervention type | Other |
| Primary outcome measure | Progression-free survival rate after 3 years of follow-up |
| Secondary outcome measures | 1. Overall survival at 3 years 2. Toxicity, according to EORTC criteria 3. Safety |
| Overall study start date | 01/09/2010 |
| Completion date | 31/08/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Histologically confirmed atypical meningioma 2. Macroscopic tumour after biopsy or subtotal resection 3. Simpson Grade 4 or 5 4. Prior photon radiotherapy to the clinical target volume (CTV) of 48 - 52 Gy 5. Beginning of study treatment no later than 12 weeks after surgery 6. Aged greater than or equal to 18 years of age 7. Karnofsky Performance Score greater than or equal to 60 8. For women with childbearing potential, adequate contraception 9. Ability of subject to understand character and individual consequences of the clinical trial 10. Written informed consent (must be available before enrolment in the trial) |
| Key exclusion criteria | 1. Refusal of the patients to take part in the study 2. Previous radiotherapy of the brain 3. Optic nerve sheath meningioma (ONSM) 4. Time interval of greater than 12 weeks after primary diagnosis (neurosurgical intervention) and beginning of study treatment 5. Patients who have not yet recovered from acute toxicities of prior therapies 6. Known carcinoma less than 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 7. Pregnant or lactating women 8. Participation in another clinical study or observation period of competing trials, respectively |
| Date of first enrolment | 01/09/2010 |
| Date of final enrolment | 31/08/2016 |
Locations
Countries of recruitment
- Germany
Study participating centre
69120
Germany
Sponsor information
Hospital/treatment centre
c/o Irmtraud Gürkan
Im Neuenheimer Feld 672
Heidelberg
69120
Germany
| Phone | +49 (0)6221 56 7002 |
|---|---|
| irmtraud.guerkan@med.uni-heidelberg.de | |
| Website | http://www.uni-heidelberg.de |
"ROR" |
https://ror.org/013czdx64 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 09/11/2010 | Yes | No |
Editorial Notes
15/04/2019: No publications found. Verifying results with principal investigator.
17/03/2016: Plain English summary and publication reference added.
