Condition category
Cancer
Date applied
21/10/2010
Date assigned
21/10/2010
Last edited
11/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Sarah Jefferies

ORCID ID

Contact details

Addenbrooke's NHS Trust Oncology Centre
Box 193
Hills Road
Cambridge
CB2 0QQ
United Kingdom
-
sarah.jefferies@addenbrookes.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00626730

Protocol/serial number

5662; EORTC protocol 22042-26042

Study information

Scientific title

Adjuvant postoperative high-dose radiotherapy for atypical and malignant meningioma: a phase-II and observation study

Acronym

Study hypothesis

This study is looking at how effective radiotherapy after surgery can be at preventing the reoccurance of meningioma, a type of brain tumour.

The aims of this study are to see:
1. How long high dose radiotherapy stops the meningioma coming back for
2. How well people cope with the treatment
3. How well people having the treatment can carry out simple instructions and tasks afterwards

Ethics approval

South East Research Ethics Committee, 05/09/2008, ref: 08/H1102/43

Study design

Multicentre non-randomised interventional phase II treatment 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 contact details to request a participant information sheet

Condition

Topic: National Cancer Research Network; Subtopic: Brain Tumour; Disease: Brain and Nervous System

Intervention

Simpson grade 1 - 3: 60 Gy to the CTV1, treatment duration 6 weeks
Simpson grade 4 - 5: 60 Gy to the CTV1 and then 10Gy boost to CTV2, treatment duration 7 weeks

Follow up on both arms: 1st follow up 6 weeks post last irradiation, 2nd follow up will be 6 months after trial entry, 3rd follow up at 12 months and yearly thereafter.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. Three year progression free survival (PFS)
2. Acute and long term toxicity

Measured at baseline, during treatment, 6 weeks after end of radiotherapy (RT), 6 months after trial entry, 12 months after trial entry and then yearly. For both endpoints, the patients not having experienced the event(s) of interest are censored at the date of most recent follow-up.

Secondary outcome measures

Overall survival (OS), measured from date of entry to date of death, irrespective of the cause.

For both endpoints, the patients not having experienced the event(s) of interest are censored at the date of most recent follow-up.

Overall trial start date

22/11/2008

Overall trial end date

28/02/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically confirmed newly diagnosed meningioma, including the following subtypes (atypical World Health Organisation [WHO] grade II meningioma greater than or equal to 4 mitosis per high-power field [HPF] or the presence of at least 3 of the following variables):
1.1. Cellularity
1.2. Architectural sheeting (i.e., patternless pattern)
1.3. Macronuclei cell formation
1.4. Small cell formation
1.5. Malignant WHO grade III meningioma
2. All locations allowed except for optic nerve sheets tumours
3. Complete or subtotal resection as assessed by the surgeon after verification with a post-operative magnetic resonance imaging (MRI) and according to Simpson guidelines
4. No neurofibromatosis type 2 (NF-2)
5. Female, aged 53 - 67 years

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned sample size: 77

Participant exclusion criteria

1. No optic nerve sheet tumours nor neurofibromatosis type II
2. No previous radiation therapy to the meninges or brain
3. No second malignancies
4. 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

Recruitment start date

22/11/2008

Recruitment end date

28/02/2011

Locations

Countries of recruitment

Belgium, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom

Trial participating centre

Addenbrooke's NHS Trust Oncology Centre
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

European Organisation for Research and Treatment of Cancer (EORTC)

Sponsor details

Avenue E. Mounier 83
Bte 11
Brussels
B-1200
Belgium
+32 2 774 16 11
nadege.gosselin@eortc.be

Sponsor type

Research organisation

Website

http://www.eortc.be

Funders

Funder type

Research organisation

Funder name

European Organisation for Research and Treatment of Cancer

Alternative name(s)

EORTC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Belgium

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

Publication citations

Additional files

Editorial Notes

11/02/2016: No publications found, verifying study status with principal investigator