Actively Recruiting
Proton Radiotherapy for Primary Central Nervous System Tumours in Adults
Led by Uppsala University · Updated on 2016-06-13
500
Participants Needed
6
Research Sites
778 weeks
Total Duration
On this page
Sponsors
U
Uppsala University
Lead Sponsor
S
Sahlgrenska University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Proton Radiotherapy for Primary Central Nervous System Tumours in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The patient must be at least 18 years old
- Have a World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 and a Karnofsky score of 60 or higher
- Be able to understand information about the treatment and give written informed consent
- Be cooperative and able to complete adequate follow-up studies
- Have a life expectancy of at least 3 years, or at least 6 months if considered for re-irradiation
- Have a pathology-proven CNS tumour or radiology findings evaluated at a multidisciplinary conference
- Women of reproductive potential must agree to use effective contraception during therapy
- Prior CNS radiotherapy is allowed, with re-irradiated patients included in a separate subgroup
- Diagnosed with one of the following: anaplastic glioma grade III with LOH 1p/19q and IDH-1 mutation, arteriovenous malformations, chordomas, chondrosarcomas, craniopharyngiomas, ependymomas, intracranial germ cell tumours, low grade gliomas grade I-II, medulloblastoma, primitive neuroectodermal tumour, meningiomas, neurocytoma, other grade I-II primary CNS tumours by WHO classification, pituitary adenomas, schwannomas, spinal tumours, or cases where craniospinal irradiation or CNS re-irradiation is considered
You will not qualify if you...
- Having concomitant or previous malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ carcinoma of the cervix uteri with at least 3 years follow-up, or other previous malignancies with at least 5 years disease-free interval
- Unable to understand information or manage tests following the study protocol unless assisted by authorized interpreters
- Having psychiatric, addictive, or other medical conditions that would prevent meeting study requirements as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Sahlgrenska University Hospital
Gothenburg, Sweden
Actively Recruiting
2
Linkoeping University Hospital
Linköping, Sweden
Actively Recruiting
3
Orebro University Hospital
Örebro, Sweden
Actively Recruiting
4
Karolinska University Hospital
Stockholm, Sweden
Actively Recruiting
5
Umea University Hospital
Umeå, Sweden
Actively Recruiting
6
Uppsala University Hospital
Uppsala, Sweden
Actively Recruiting
Research Team
P
Petra Witt Nystrom, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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