NCT02797366

Proton Radiotherapy for Primary Central Nervous System Tumours in Adults

Proton Radiotherapy for Primary Central Nervous System Tumours in Adults - a Prospective Swedish Multicentre Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Open label, multi-centre prospective study. Adult patients with primary central nervous system tumours fulfilling the inclusion criteria according to the study protocol. The study consists of 2 sequential cohorts evaluated consecutively for the feasibility, safety and toxicity, as well as long-term survival data, when using spot scanning proton beam therapy.

Detailed description

Open label, multi-centre prospective phase II study. Adult patients with primary central nervous system tumours full-filling the inclusion criteria according to the study protocol. The study consists of 2 sequential cohorts evaluated for the feasibility, safety and toxicity, as well as long-term survival data, when using proton beam therapy. * Part I: To assess the feasibility of using pencil beam scanning and evaluating the treatment safety in all aspects, and to assess acute toxicity in a smaller cohort of CNS patients. All toxicity data, QoL and survival data will also be included in the part II cohort. * Part II: The second part of the trial consists of all CNS patients that are referred to the Skandion Clinic after the safety data from the first part has been evaluated by the study steering committee.

Conditions

• Central Nervous System Tumour
• Arteriovenous Malformation

Interventions

Type	Name	Description
RADIATION	Proton radiotherapy

Timeline

• Start date: 2015-08-01
• Primary completion: 2020-07-01
• Completion: 2030-07-01
• First posted: 2016-06-13
• Last updated: 2016-06-13

Locations

6 sites across 1 country: Sweden