Proton Radiotherapy for Primary Central Nervous System Tumours in Adults

NCT02797366 | Recruiting Phase 2

• 1 other identifier: PRO-CNS
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 6

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.

Conditions

Central Nervous System Tumour; Arteriovenous Malformation

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Local and regional tumour control

  15 years

• Pattern of failure

  15 years

• Quality of life

  5 years

• Normal tissue sparing and normal tissue complication

  15 years

Study Arms (1)

Proton radiotherapy

OTHER

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

Radiation: Proton radiotherapy

Interventions

Proton radiotherapy RADIATION

Proton radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uppsala University: lead
• Sahlgrenska University Hospital: collaborator
• Karolinska University Hospital: collaborator
• University Hospital, Umeå: collaborator
• Region Örebro County: collaborator
• University Hospital, Linkoeping: collaborator

Study Sites (6)

Sahlgrenska University Hospital

Gothenburg, Sweden

RECRUITING

Linkoeping University Hospital

Linköping, Sweden

RECRUITING

Orebro University Hospital

Örebro, Sweden

RECRUITING

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

Umea University Hospital

Umeå, Sweden

RECRUITING

Uppsala University Hospital

Uppsala, Sweden

RECRUITING

MeSH Terms

Conditions

Arteriovenous Malformations

Condition Hierarchy (Ancestors)

Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Petra Witt Nystrom, MD, PhD

  Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Petra Witt Nystrom, MD, PhD

CONTACT

petra.witt@akademiska.se

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: June 13, 2016
• Study Start: August 1, 2015
• Primary Completion: July 1, 2020
• Study Completion (Estimated): July 1, 2030
• Last Updated: June 13, 2016

Record last verified: 2016-06

Locations

SE (6)