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

Phase 2

Completed

• Conditions: Benign neoplasm of brain and other parts of central nervous system; Atypical meningioma; Cancer

• Registration Number: ISRCTN58692836
• Lead Sponsor: niversity Hospital of Heidelberg (Germany)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-07
• Study Completion: 2016-08-31
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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)

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival rate after 3 years of follow-up

Secondary Outcome Measures

Name	Time	Method
<br> 1. Overall survival at 3 years<br> 2. Toxicity, according to EORTC criteria<br> 3. Safety<br>