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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
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Central Nervous System Tumour Arteriovenous Malformation Radiation: Proton radiotherapy Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Arms and Interventions

Arm Intervention/treatment
Proton radiotherapy
Proton radiation therapy daily (Monday through Friday) for 4-8 weeks. This is a single arm study.
Radiation: Proton radiotherapy

Outcome Measures

Primary Outcome Measures :
  1. Acute adverse events [ Time Frame: 3 months ]
  2. 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.

Secondary Outcome Measures :
  1. Local and regional tumour control [ Time Frame: 15 years ]
    Including overall survival

  2. Pattern of failure [ Time Frame: 15 years ]
    Pattern of failure on MRI will be compared with patients getting conventional radiotherapy.

  3. 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.

  4. 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).

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797366

Contact: Petra Witt Nystrom, MD, PhD petra.witt@akademiska.se

Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden
Contact: Katja Werlenius, MD         
Linkoeping University Hospital Recruiting
Linkoping, Sweden
Contact: Anna Flejmer, MD         
Orebro University Hospital Recruiting
Orebro, Sweden
Contact: Eva Tegnelius, MD         
Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Teresa Herlestam-Carlero, MD, PhD         
Umea University Hospital Recruiting
Umeå, Sweden
Contact: Per Bergstrom, MD         
Uppsala University Hospital Recruiting
Uppsala, Sweden
Contact: Petra Witt Nyström, Md, PhD         
Sponsors and Collaborators
Uppsala University
Sahlgrenska University Hospital, Sweden
Karolinska University Hospital
University Hospital, Umeå
Region Örebro County
University Hospital, Linkoeping
Principal Investigator: Petra Witt Nystrom, MD, PhD Uppsala University Hospital
More Information

Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT02797366     History of Changes
Other Study ID Numbers: PRO-CNS
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: June 13, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Congenital Abnormalities
Arteriovenous Malformations
Neoplasms by Site
Nervous System Diseases
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type