NCT02797366 Proton Radiotherapy for Primary Central Nervous System Tumours in Adults
| NCT ID | NCT02797366 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Uppsala University |
| Condition | Central Nervous System Tumour |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2015-08 |
| Primary Completion | 2020-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 500 participants in total. It began in 2015-08 with a primary completion date of 2020-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Petra Witt Nystrom, MD, PhD
✉ petra.witt@akademiska.sePetra Witt Nystrom, MD, PhD
PRINCIPAL INVESTIGATOR
Uppsala University Hospital
Frequently Asked Questions
Who can join the NCT02797366 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Central Nervous System Tumour. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02797366 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT02797366 currently recruiting?
Yes, NCT02797366 is actively recruiting participants. Contact the research team at petra.witt@akademiska.se for enrollment information.
Where is the NCT02797366 trial being conducted?
This trial is being conducted at Gothenburg, Sweden, Linköping, Sweden, Örebro, Sweden, Stockholm, Sweden and 2 additional locations.
Who is sponsoring the NCT02797366 clinical trial?
NCT02797366 is sponsored by Uppsala University. The principal investigator is Petra Witt Nystrom, MD, PhD at Uppsala University Hospital. The trial plans to enroll 500 participants.