Clinical Trial Details
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NCT02797366 : Proton Radiotherapy for Primary Central Nervous System Tumours in Adults
PhasePhase 2
AgesMin: 18 Years Max: N/A
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

- 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.
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