Proton radiotherapy for adult brain tumors
Proton Radiotherapy for Primary Central Nervous System Tumours in Adults - a Prospective Swedish Multicentre Study
This study is testing whether proton beam therapy is a safe and effective treatment for adults with brain tumors to see how it affects their survival and quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Uppsala University Academic / other |
| Locations | 6 sites (Gothenburg and 5 other locations) |
| Trial ID | NCT02797366 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a pathology-proven CNS tumor and a life expectancy of at least 3 years.
Not a fit: Patients with a life expectancy of less than 3 years or those who are uncooperative may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer and more effective option for patients with primary central nervous system tumors.
How similar studies have performed: Other studies using proton beam therapy have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Gothenburg and 5 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.