Proton Radiotherapy for Primary Central Nervous System Tumours in Adults - a Prospective Swedish Multicentre Study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Central Nervous System Tumour
- Sponsor
- Uppsala University
- Enrollment
- 500
- Locations
- 6
- Primary Endpoint
- Acute adverse events
- Status
- Recruiting
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Acute adverse events
Time Frame: 3 months
Long-term adverse events
Time Frame: 10-15 years
This study specifically includes longitudinal follow-up to assess the incidence of neurotoxicity including cognitive dysfunction, as well as the incidence of secondary malignant neoplasms at 10 and 15 years following radiotherapy.
Secondary Outcomes
- Local and regional tumour control(15 years)
- Pattern of failure(15 years)
- Quality of life(5 years)
- Normal tissue sparing and normal tissue complication(15 years)