Proton Radiotherapy for Primary Central Nervous System Tumours in Adults

Phase 2

Recruiting

• Conditions: Central Nervous System Tumour; Arteriovenous Malformation
• Interventions: Radiation: Proton radiotherapy

• Registration Number: NCT02797366
• Lead Sponsor: Uppsala University

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.

Detailed Description

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 Timeline

• Study Start: 2015-08
• Study First Submitted: 2016-05-18
• Status Verified: 2016-06
• Study First Submitted QC: 2016-06-07
• Last Update Submitted: 2016-06-07
• Study First Posted: 2016-06-13
• Last Update Posted: 2016-06-13
• Primary Completion: 2020-07
• Study Completion: 2030-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Proton radiotherapy	Proton radiotherapy	Proton radiation therapy daily (Monday through Friday) for 4-8 weeks. This is a single arm study.

Primary Outcome Measures

Name	Time	Method
Acute adverse events	3 months
Long-term adverse events	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.

Secondary Outcome Measures

Name	Time	Method
Local and regional tumour control	15 years	Including overall survival
Pattern of failure	15 years	Pattern of failure on MRI will be compared with patients getting conventional radiotherapy.
Quality of life	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	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).

Trial Locations

Locations (6)

Linkoeping University Hospital; 🇸🇪 Linkoping, Sweden

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Umea University Hospital; 🇸🇪 Umeå, Sweden

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden

Orebro University Hospital; 🇸🇪 Orebro, Sweden