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| Name | Class |
|---|---|
| Sahlgrenska University Hospital | OTHER |
| Karolinska University Hospital | OTHER |
| University Hospital, Umeå | OTHER |
| Region Örebro County |
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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.
Open label, multi-centre prospective phase II study. Adult patients with primary central nervous system tumours full-filling the inclusion criteria according to the study protocol. The study consists of 2 sequential cohorts evaluated for the feasibility, safety and toxicity, as well as long-term survival data, when using proton beam therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proton radiotherapy | Other | Proton radiation therapy daily (Monday through Friday) for 4-8 weeks. This is a single arm study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton radiotherapy | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute adverse events | 3 months | |
| Long-term adverse events | 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. | 10-15 years |
| Measure | Description | Time Frame |
|---|---|---|
| Local and regional tumour control | Including overall survival | 15 years |
| Pattern of failure | Pattern of failure on MRI will be compared with patients getting conventional radiotherapy. |
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Inclusion criteria:
Patients discussed at multidisciplinary conferences at one of the seven university hospitals in Sweden and found candidates for radiotherapy and one of following diagnoses:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Petra Witt Nystrom, MD, PhD | Contact | petra.witt@akademiska.se |
| Name | Affiliation | Role |
|---|---|---|
| Petra Witt Nystrom, MD, PhD | Uppsala University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Recruiting | Gothenburg | Sweden |
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| ID | Term |
|---|---|
| D001165 | Arteriovenous Malformations |
| ID | Term |
|---|---|
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| OTHER |
| University Hospital, Linkoeping | OTHER |
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| 15 years |
| Quality of life | Quality of Life (QoL) data will be evaluated using validated questionnaires from the European Organization for Research and Treatment of Cancer (EORTC): EORTC-QLQ-C30 is a multidimensional, cancer-specific QoL questionnaire developed for repeated assessments in clinical trials, and validated in various cancer populations. The Brain Cancer Module (EORTC-QLQ-BN20) includes 20 questions focusing on neurological symptoms and EuroQoL (EQ-5D) may additional also be used in the study. | 5 years |
| Normal tissue sparing and normal tissue complication | Normal tissue complication probability (NTCP) models will be used to evaluate the reduction in normal tissue complications in dose planning studies comparing proton radiotherapy vs. 3D-Conformal Radiotherapy (CRT), Intensity Modulated Radiotherapy (IMRT)/Volumetric Modulated Arc Therapy (VMAT)/Helical Tomotherapy (HTT). | 15 years |
| Linkoeping University Hospital | Recruiting | Linköping | Sweden |
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| Orebro University Hospital | Recruiting | Örebro | Sweden |
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| Karolinska University Hospital | Recruiting | Stockholm | Sweden |
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| Umea University Hospital | Recruiting | Umeå | Sweden |
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| Uppsala University Hospital | Recruiting | Uppsala | Sweden |
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| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |