NCT02978677

Brief Summary

The trial evaluates the effect of a moderately increased radiation dose in patients with atypical (grade II) and anaplastic (grade III) meningioma after incomplete or no surgery. Endpoint is recurrence-free survival after 5 years.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
43mo left

Started Oct 2022

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Oct 2022Dec 2029

First Submitted

Initial submission to the registry

October 19, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 1, 2016

Completed
5.8 years until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

6.2 years

First QC Date

October 19, 2016

Last Update Submit

August 2, 2022

Conditions

Meningioma

Keywords

brain tumorsproton radiotherapyphoton radiotherapy

Outcome Measures

Primary Outcomes (1)

  • progression-free survival

    5 years after start of radiotherapy

Secondary Outcomes (5)

  • late toxicity

    5 years after start of radiotherapy

  • acute toxicity

    5 years after start of radiotherapy

  • overall survival

    5 years after start of radiotherapy

  • patterns of recurrence using MRI

    5 years after start of radiotherapy

  • quality of life by validated quality of life questionnaires

    5 years after start of radiotherapy

Study Arms (3)

Grade II tumors (macroscopic)

EXPERIMENTAL

Radiotherapy 68 Gy(RBE)

Radiation: Radiotherapy 68 Gy(RBE)

Grade III tumors (macroscopic)

EXPERIMENTAL

Radiotherapy 72 Gy(RBE)

Radiation: Radiotherapy 72 Gy(RBE)

Grade II/III tumors (completely resected)

ACTIVE COMPARATOR

Radiotherapy 60 Gy(RBE)

Radiation: Radiotherapy 60 Gy(RBE)

Interventions

Radiotherapy 68 Gy(RBE)RADIATION

Radiotherapy 2.0 to 50 Gy(RBE) photon or proton and boost 2 to 18 Gy(RBE) proton

Grade II tumors (macroscopic)
Radiotherapy 72 Gy(RBE)RADIATION

Radiotherapy 2.0 to 50 Gy(RBE) photon or proton and boost 2 to 18 Gy(RBE) proton and boost 2 to 4 Gy(RBE) proton

Grade III tumors (macroscopic)
Radiotherapy 60 Gy(RBE)RADIATION

Radiotherapy 2.0 to 50 Gy(RBE) photon or proton and boost 2 to 10 Gy(RBE) proton

Grade II/III tumors (completely resected)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically confirmed atypical (WHO grade II) or anaplastic (WHO grade III) meningioma with the indication for radiotherapy
  • MRI (within 24h post-operative, if not available than with a time interval of \~ 6 weeks) including contrast-enhanced T1 weighted 3D dataset and PET for evaluation of macroscopic tumour (residuum)
  • Karnofsky Performance Score ≥ 60, ECOG ≤2
  • For women with childbearing potential, (and men) adequate contraception.
  • Ability of subject to understand character and individual consequences of the clinical trial
  • Written informed consent (must be available before enrolment in the trial)

You may not qualify if:

  • refusal of the patients to take part in the study
  • previous radiotherapy of the brain
  • several manifestations of the meningioma in different regions of the brain or additional spinal manifestations
  • distant metastases
  • patients who are not suitable for radiotherapy
  • known other malignant disease within 5 years before radiotherapy (except tumours that likely do not impact prognosis and likely not require treatment interfering with study therapy, e.g. in-situ carcinoma of the breast or cervix uteri)
  • pregnant or lactating women
  • patients with non-MRI compatible metal implants, pacemaker or non-MRI compatible external automatic defibrillators
  • patients not able to understand character and individual consequences of the clinical trial
  • claustrophobic patients
  • current participation in another clinical intervention study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

MeningiomaBrain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular TissueMeningeal NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNervous System DiseasesBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Mechthild Krause, Prof.

    Technische Universität Dresden, German Cancer Consortium, Helmholtz-Zentrum Dresden - Rossendorf

    STUDY CHAIR

Central Study Contacts

Mechthild Krause, Prof.

CONTACT

+49 351 458 5441mechthild.krause@uniklinikum-dresden.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 19, 2016

First Posted

December 1, 2016

Study Start

October 1, 2022

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2029

Last Updated

August 3, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share