Proton Radiotherapy for Primary Central Nervous System Tumours in Adults (PRO-CNS)
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|ClinicalTrials.gov Identifier: NCT02797366|
Recruitment Status : Recruiting
First Posted : June 13, 2016
Last Update Posted : June 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Central Nervous System Tumour Arteriovenous Malformation||Radiation: Proton radiotherapy||Phase 2|
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.
- Part I: To assess the feasibility of using pencil beam scanning and evaluating the treatment safety in all aspects, and to assess acute toxicity in a smaller cohort of CNS patients. All toxicity data, QoL and survival data will also be included in the part II cohort.
- Part II: The second part of the trial consists of all CNS patients that are referred to the Skandion Clinic after the safety data from the first part has been evaluated by the study steering committee.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Proton Radiotherapy for Primary Central Nervous System Tumours in Adults - a Prospective Swedish Multicentre Study|
|Study Start Date :||August 2015|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2030|
Proton radiation therapy daily (Monday through Friday) for 4-8 weeks. This is a single arm study.
Radiation: Proton radiotherapy
- Acute adverse events [ Time Frame: 3 months ]
- Long-term adverse events [ Time Frame: 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.
- Local and regional tumour control [ Time Frame: 15 years ]Including overall survival
- Pattern of failure [ Time Frame: 15 years ]Pattern of failure on MRI will be compared with patients getting conventional radiotherapy.
- Quality of life [ Time Frame: 5 years ]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.
- Normal tissue sparing and normal tissue complication [ Time Frame: 15 years ]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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797366
|Contact: Petra Witt Nystrom, MD, PhDfirstname.lastname@example.org|
|Sahlgrenska University Hospital||Recruiting|
|Contact: Katja Werlenius, MD|
|Linkoeping University Hospital||Recruiting|
|Contact: Anna Flejmer, MD|
|Orebro University Hospital||Recruiting|
|Contact: Eva Tegnelius, MD|
|Karolinska University Hospital||Recruiting|
|Contact: Teresa Herlestam-Carlero, MD, PhD|
|Umea University Hospital||Recruiting|
|Contact: Per Bergstrom, MD|
|Uppsala University Hospital||Recruiting|
|Contact: Petra Witt Nyström, Md, PhD|
|Principal Investigator:||Petra Witt Nystrom, MD, PhD||Uppsala University Hospital|