Ireland
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Recruiting Phase 2

Proton Radiotherapy for Primary Central Nervous System Tumours in Adults

NCT02797366 · tracked via the Priya Life Science Sweden tracker
Phase
Phase 2
Started
2015-08
Last updated
2016-06-13

Condition(s) studied

Central Nervous System TumourArteriovenous Malformation

Investigational drug(s) / intervention(s)

Proton radiotherapy

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Acute adverse events — 3 months
  • Long-term adverse events — 10-15 years
    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.

Trial sites (6)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02797366 on ClinicalTrials.gov ↗ ← All trials in Sweden