NCT02978677

Proton Dose Escalation for Patients With Atypical or Anaplastic Meningiomas

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Technische Universität Dresden · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Meningioma

Interventions

Type	Name	Description
RADIATION	Radiotherapy 68 Gy(RBE)	Radiotherapy 2.0 to 50 Gy(RBE) photon or proton and boost 2 to 18 Gy(RBE) proton
RADIATION	Radiotherapy 72 Gy(RBE)	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
RADIATION	Radiotherapy 60 Gy(RBE)	Radiotherapy 2.0 to 50 Gy(RBE) photon or proton and boost 2 to 10 Gy(RBE) proton

Timeline

• Start date: 2022-10-01
• Primary completion: 2028-12-01
• Completion: 2029-12-01
• First posted: 2016-12-01
• Last updated: 2022-08-03