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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
500
Sahlgrenska University Hospital
Gothenburg, Sweden
RECRUITINGLinkoeping University Hospital
Linköping, Sweden
RECRUITINGOrebro University Hospital
Örebro, Sweden
Acute adverse events
Time frame: 3 months
Long-term adverse events
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.
Time frame: 10-15 years
Local and regional tumour control
Including overall survival
Time frame: 15 years
Pattern of failure
Pattern of failure on MRI will be compared with patients getting conventional radiotherapy.
Time frame: 15 years
Quality of life
Quality of Life (QoL) data will be evaluated using validated questionnaires from the European Organization for Research and Treatment of Cancer (EORTC): EORTC-QLQ-C30 is a multidimensional, cancer-specific QoL questionnaire developed for repeated assessments in clinical trials, and validated in various cancer populations. The Brain Cancer Module (EORTC-QLQ-BN20) includes 20 questions focusing on neurological symptoms and EuroQoL (EQ-5D) may additional also be used in the study.
Time frame: 5 years
Normal tissue sparing and normal tissue complication
Normal tissue complication probability (NTCP) models will be used to evaluate the reduction in normal tissue complications in dose planning studies comparing proton radiotherapy vs. 3D-Conformal Radiotherapy (CRT), Intensity Modulated Radiotherapy (IMRT)/Volumetric Modulated Arc Therapy (VMAT)/Helical Tomotherapy (HTT).
Time frame: 15 years
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Karolinska University Hospital
Stockholm, Sweden
RECRUITINGUmea University Hospital
Umeå, Sweden
RECRUITINGUppsala University Hospital
Uppsala, Sweden
RECRUITING