Proton radiotherapy for adult brain tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open label, multi-centre phase II study evaluating the feasibility, safety, and long-term survival outcomes of proton beam therapy in adult patients with primary central nervous system tumors. The study is divided into two parts: the first part assesses the safety and acute toxicity in a smaller cohort, while the second part includes all CNS patients referred to the Skandion Clinic after safety data evaluation. The study aims to gather comprehensive data on treatment effects and quality of life.

Why it matters

Who can join: the full rules

Inclusion criteria:

* 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.
* Must have a life expectancy of at least 3 years based on age and co-morbidities as well as diagnosis. For patients considered for re-irradiation the life expectancy must be estimated to minimum 6 months.
* Must have a pathology proven CNS tumour or if not possible, the radiology findings must be evaluated at a multi-disciplinary conference at a university hospital.
* Women of reproductive potential must agree to use an effective method of contraception during therapy such as an intrauterine device or condom. Pregnancy IS not an ineligibility criteria if radiotherapy is indicated and can-not be postponed.
* Prior CNS radiotherapy is not an ineligibility criteria but re-irradiated patients will be included in a subgroup evaluated separately.

Patients discussed at multidisciplinary conferences at one of the seven university hospitals in Sweden and found candidates for radiotherapy and one of following diagnoses:

* Anaplastic glioma grade III with Loss of Heterozygosity (LOH) 1p/19q and isocitrate dehydrogenase-1 (IDH-1) mutation
* Arteriovenous malformations (AVMs)
* Chordomas and chondrosarcomas
* Craniopharyngiomas
* Ependymomas
* Intracranial germ cell tumours
* Low grade gliomas - grade I-II
* Medulloblastoma, Primitive neuroectodermal tumour (PNET)
* Meningiomas
* Neurocytoma
* Other grade I-II primary CNS tumour according to WHO classification
* Pituitary adenomas
* Schwannomas
* Spinal tumours
* Whenever craniospinal irradiation (CSI) is indicated
* Whenever re-irradiation of CNS is considered

Exclusion criteria:

* 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.

Where it's running

• Sahlgrenska University Hospital
  Gothenburg, Sweden Recruiting
• Linkoeping University Hospital
  Linköping, Sweden Recruiting
• Orebro University Hospital
  Örebro, Sweden Recruiting
• Karolinska University Hospital
  Stockholm, Sweden Recruiting
• Umea University Hospital
  Umeå, Sweden Recruiting
• Uppsala University Hospital
  Uppsala, Sweden Recruiting

Study contacts

• Principal investigator: Petra Witt Nystrom, MD, PhD — Uppsala University Hospital
• Study coordinator: Petra Witt Nystrom, MD, PhD
• Email: petra.witt@akademiska.se

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.