Condition category
Cancer
Date applied
10/07/2010
Date assigned
07/02/2011
Last edited
17/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.uni-heidelberg.de

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

Results - basic reporting

Publication summary

2010 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/21062428

Publication citations

Additional files

Editorial Notes

17/03/2016: Plain English summary and publication reference added.