Clinical Trial: Proton Dose Escalation for Patients With Atypical or Anaplastic Meningiomas
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Proton Dose Escalation for Patients With Atypical or Anaplastic Meningiomas
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.
Detailed Summary:
The trial intends to optimize treatment for grade II and grade III (atypical or anaplastic) meningioma. Standard treatment for atypical or anaplastic meningioma is surgery. For grade III (anaplastic) meningiomas, post-operative radiotherapy would be performed in all cases using standard fractionation schedules to a total dose of ~60 Gy. For grade II (atypical) meningiomas, although some small patient datasets support early onset of radiotherapy, the standard treatment is still to irradiate if tumours are recurrent or if resection was macroscopically incomplete. Total doses of 54 to ~60 Gy are applied using standard fractionation schedules.
A major problem of the treatment of atypical or anaplastic meningioma is that beyond surgery and radiotherapy, there are only experimental treatment options and the probability of local recurrences is 50-100% within the first 5 years for grade II and grade III meningioma.
The present trial has been developed to evaluate efficacy of a dose-intensified radiotherapy treatment schedule for incompletely or not resected meningioma to a total dose of 68 (grade II) or 72 Gy (grade III). To minimize normal tissue toxicity, the boost dose or the complete radiotherapy is applied using protons. The expectation is a higher recurrence-free survival compared to previous reports on outcome of standard dose (60 Gy) radiotherapy.
Sponsor: Technische Universität Dresden
Current Primary Outcome: progression-free survival [ Time Frame: 5 years after start of radiotherapy ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- late toxicity [ Time Frame: 5 years after start of radiotherapy ]CTC-AE 4.0
- acute toxicity [ Time Frame: 5 years after start of radiotherapy ]CTC-AE 4.0
- overall survival [ Time Frame: 5 years after start of radiotherapy ]
- patterns of recurrence using MRI [ Time Frame: 5 years after start of radiotherapy ]
- quality of life by validated quality of life questionnaires [ Time Frame: 5 years after start of radiotherapy ]EORTC-QLQ-C30, EORTC-QLQ-BN20
Original Secondary Outcome: Same as current
Information By: Technische Universität Dresden
Dates:
Date Received: October 19, 2016
Date Started: January 2017
Date Completion: December 2027
Last Updated: November 28, 2016
Last Verified: November 2016