Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Prof Jürgen Debus
ORCID ID
Contact details
University Hospital of Heidelberg
Department of Radiation Oncology
Im Neuenheimer Feld 400
Heidelberg
69120
Germany
+49 (0)6221 56 8201
juergen.debus@med.uni-heidelberg.de
Additional identifiers
EudraCT number
2009-016683-36
ClinicalTrials.gov number
NCT01166321
Protocol/serial number
EudraCT No.:2009-016683-36
Study information
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
Acronym
MARCIE
Study hypothesis
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
Local medical ethics committee (Ethikkommission der Medizinischen Fakultät Heidelberg), 21/01/2010, ref: S444-2009
Study design
Single-arm phase II trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Phase II
Drug names
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 trial start date
01/09/2010
Overall trial end date
31/08/2016
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant 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
Recruitment start date
01/09/2010
Recruitment end date
31/08/2016
Locations
Countries of recruitment
Germany
Trial participating centre
University Hospital of Heidelberg
Heidelberg
69120
Germany
Sponsor information
Organisation
University Hospital of Heidelberg (Germany)
Sponsor details
c/o Irmtraud Gürkan
Im Neuenheimer Feld 672
Heidelberg
69120
Germany
+49 (0)6221 56 7002
irmtraud.guerkan@med.uni-heidelberg.de
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospital of Heidelberg (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/21062428