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
Qualifiers
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
Treatments tested in this trial
- Proton radiotherapy
Treatment groups
500 Participants
are divided into 1 treatment groupSponsors and collaborators
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