Proton Radiotherapy for Primary Central Nervous System Tumours in Adults
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUppsala University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patient must be at least 18 years old
World Health Organization (WHO)/ Eastern Cooperative OncologyGroup (ECOG) performance status 0-2, Karnofsky score ≥60.
The patient must be able to understand the information about the treatment and give a written informed consent to participate in the trial.
Adequate follow-up study must be possible; this will exclude a patient who is uncooperative.
Disqualifiers
Concomitant or previous malignancies. Exceptions are adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix uteri with a follow-up time of at least 3 years, or other previous malignancy with a disease-free interval of at least 5 years.
Not able to understand information or manage tests according to study protocol. If necessary, only authorized interpreters may be used to assist in the translation.
Psychiatric or addictive disorders or other medical conditions that, in the opinions of the investigator, would preclude the patient from meeting the study requirements.
Trial design
Design model
Single group
Treatments tested in this trial
Proton radiotherapy
Radiation
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Proton radiotherapyOther 1 intervention
Trial outcomes
Primary outcomes
1
Acute adverse events
Time frame
3 months2
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 yearsSecondary outcomes
1
Local and regional tumour control
Including overall survival
Time frame
15 years2
Pattern of failure
Pattern of failure on MRI will be compared with patients getting conventional radiotherapy.
Time frame
15 years3
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 years4
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 yearsSponsors and contacts
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Uppsala University
Lead sponsor
Sahlgrenska University Hospital
Collaborator
Karolinska University Hospital
Collaborator
University Hospital, Umeå
Collaborator
Region Örebro County
Collaborator
University Hospital, Linkoeping
Collaborator
Source ClinicalTrials.gov