Proton Radiotherapy for Primary Central Nervous System Tumours in Adults

Last updated: June 7, 2016
Sponsor: Uppsala University
Overall Status: Active - Recruiting

Phase

2

Condition

Hemangioma

Birth Defects

Holoprosencephaly

Treatment

N/A

Clinical Study ID

NCT02797366
PRO-CNS
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • The patient must be at least 18 years old

  • World Health Organization (WHO)/ Eastern Cooperative OncologyGroup (ECOG) performancestatus 0-2, Karnofsky score ≥60.

  • The patient must be able to understand the information about the treatment and give awritten informed consent to participate in the trial.

  • Adequate follow-up study must be possible; this will exclude a patient who isuncooperative.

  • Must have a life expectancy of at least 3 years based on age and co-morbidities aswell as diagnosis. For patients considered for re-irradiation the life expectancy mustbe estimated to minimum 6 months.

  • Must have a pathology proven CNS tumour or if not possible, the radiology findingsmust be evaluated at a multi-disciplinary conference at a university hospital.

  • Women of reproductive potential must agree to use an effective method of contraceptionduring therapy such as an intrauterine device or condom. Pregnancy IS not anineligibility criteria if radiotherapy is indicated and can-not be postponed.

  • Prior CNS radiotherapy is not an ineligibility criteria but re-irradiated patientswill be included in a subgroup evaluated separately. Patients discussed at multidisciplinary conferences at one of the seven universityhospitals in Sweden and found candidates for radiotherapy and one of following diagnoses:

  • Anaplastic glioma grade III with Loss of Heterozygosity (LOH) 1p/19q and isocitratedehydrogenase-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

Exclusion criteria:

  • Concomitant or previous malignancies. Exceptions are adequately treated basal cellcarcinoma or squamous cell carcinoma of the skin, or in situ carcinoma of the cervixuteri with a follow-up time of at least 3 years, or other previous malignancy with adisease-free interval of at least 5 years.

  • Not able to understand information or manage tests according to study protocol. Ifnecessary, only authorized interpreters may be used to assist in the translation.

  • Psychiatric or addictive disorders or other medical conditions that, in the opinionsof the investigator, would preclude the patient from meeting the study requirements.

Study Design

Total Participants: 500
Study Start date:
August 01, 2015
Estimated Completion Date:
July 31, 2030

Study 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.

Connect with a study center

  • Sahlgrenska University Hospital

    Gothenburg,
    Sweden

    Active - Recruiting

  • Linkoeping University Hospital

    Linkoping,
    Sweden

    Active - Recruiting

  • Orebro University Hospital

    Orebro,
    Sweden

    Active - Recruiting

  • Karolinska University Hospital

    Stockholm,
    Sweden

    Active - Recruiting

  • Umea University Hospital

    Umeå,
    Sweden

    Active - Recruiting

  • Uppsala University Hospital

    Uppsala,
    Sweden

    Active - Recruiting

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