Radiation versus observation following surgical resection of atypical meningioma

Phase 3

• Conditions: Atypical meningioma; Cancer; Benign neoplasm of meninges

• Registration Number: ISRCTN71502099
• Lead Sponsor: The Walton Centre NHS Foundation Trust (UK)

Brief Summary

2015 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/26576533 protocol 2020 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/32045067 qualiatative analysis (added 12/02/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-19
• Last Update Posted: 15 August 2022
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 157

Inclusion Criteria

Current inclusion criteria as of 03/05/2017:
1. Histologically confirmed newly diagnosed solitary atypical meningioma (WHO grade II) based on the 2016 WHO criteria
2. Age >/= 16 years
3. All anatomical locations allowed except optic nerve sheath tumour
4. Complete resection (Simpson 1, 2 or 3) as assessed by the surgeon
5. Able to commence radiotherapy between within 12 weeks of surgery (ideally 8-12 weeks)
6. WHO performance status 0, 1 or 2
7. Women of reproductive potential must use effective contraception for the whole duration of the treatment
8. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Previous inclusion criteria:
1. Histologically confirmed newly diagnosed solitary atypical meningioma (WHO grade II) based on the 2007 WHO criteria
2. Age 16 years or over
3. All anatomical locations allowed except optic nerve sheath tumour
4. Complete resection (Simpson grade I, II or III) as assessed by the surgeon
5. Able to commence radiotherapy between 8 and 12 weeks after surgery
6. WHO performance status 0-2

Exclusion Criteria

Current exclusion criteria as of 05/04/2019:
1. Neurofibromatosis type II (NF-2)
2. Optic nerve sheath tumours
3. Multiple meningiomas
4. Radiation-induced meningioma
5. Clinical evidence of second malignancy, except for cervix carcinoma in situ or basal cell carcinoma, and history of invasive malignancy unless treated with curative intent and the patient has been disease free for the last five years
6. Previous intracranial tumour in the last 10 years treated with radiotherapy or chemotherapy
7. Pregnant or lactating women.

Previous exclusion criteria as of 03/05/2017:
1. Neurofibromatosis type II (NF-2)
2. Optic nerve sheath tumours
3. Multiple meningiomas
4. Radiation-induced meningioma
5. Clinical evidence of second malignancy, except for cervix carcinoma in situ or basal cell carcinoma, and history of invasive malignancy unless treated with curative intent and the patient has not been disease free for the last five years
6. Previous intracranial tumour
7. Pregnant or lactating women

Previous exclusion criteria:
1. Neurofibromatosis type II (NF-2)
2. Multiple meningiomas
3. Previous radiotherapy to the brain or meninges interfering with the protocol treatment plan
4. Clinical evidence of second malignancies, except a history of cervix carcinoma in situ and/or basal cell carcinoma
5. Pregnant or lactating women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measure as of 05/04/2019:<br> Time to MRI evidence of tumour recurrence or death due to any cause (disease free survival [DFS]). (DFS will be counted from the date of surgery until the date of MRI evidence of tumour recurrence or death due to any cause. Only clear dural thickening as identified by the investigator is to be considered tumour.)<br><br> Previous primary outcome measure:<br> Time to MRI evidence of tumour recurrence [disease free survival (DFS)] is assessed at baseline, 6 and 12 months following surgery and annually thereafter for a minimum of 5 years post-surgery.<br>