Standard Follow-up Program Neuro-oncology Patients (SFP Neuro-Oncology)
NCT Number: NCT06528912
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Neurological Cancer
Interventions: OTHER: Radiotherapy
Sponsor: University Medical Center Groningen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2017-12-01
Completion Date: 2040-01
Locations: UMCG, Groningen, 9713GZ, Netherlands

Summary:
Standardised evaluation of baseline data regarding tumor-, patient- and treatment-characteristics as well as follow-up data regarding tumor- and clinical-outcome of neuro-oncology patients treated with radical/curative radiotherapy.

Motive:

Currently there is limited data on dose-effect relationships of tissues and structures in and around the brain. This lack of knowledge hampers patient selection for proton therapy, technique innovations, and accurate prediction of treatment outcome.

Goal:

To evaluate the selection for radiation treatment, obtain more knowledge on dose-effect relationships and enable insight in necessary treatment technique innovations that would improve treatment outcome.

Primary Outcome Measures: Treatment associated CNS toxicity, Treatment associated CNS Toxicity, Before start of radiation therapy, at 2,5 years; 5 years 7,5 years, 10 years and 12,5 years after completion of radiation therapy.|Radionecrosis, Treatment associated radionecrosos measured with CTCAE, Before start of radiation therapy, at 2,5 years; 5 years 7,5 years, 10 years and 12,5 years after completion of radiation therapy.
Secondary Outcome Measures: Treatment associated non-CNS toxicity, Treatment associated non-CNS toxicity, Before start of radiation therapy, at 2,5 years; 5 years 7,5 years, 10 years and 12,5 years after completion of radiation therapy|Overall survival, Overall survival, Before start of radiation therapy, at 2,5 years; 5 years 7,5 years, 10 years and 12,5 years after completion of radiation therapy.|Progression free survival, Progression free survival, Before start of radiation therapy, at 2,5 years; 5 years 7,5 years, 10 years and 12,5 years after completion of radiation therapy
Other Outcome Measures: Patient-rated Quality of Life, Patient-rated quality of Life is measured with the Quality-of-Life Questionnaire-C30 (EORTC QLQ-C30), Before start of radiation therapy, at 2,5 years; 5 years 7,5 years, 10 years and 12,5 years after completion of radiation therapy.|Patient-rated Quality of Life, Patient-rated quality of Life is measured with the Quality-of-Life Questionnaire Brain Cancer module (EORTC QLQ-BN20), Before start of radiation therapy, at 2,5 years; 5 years 7,5 years, 10 years and 12,5 years after completion of radiation therapy.|Patient-rated Quality of Life, Patient-rated quality of Life is measured with the EuroQol Health questionnaire 5-level version (EuroQoL-5D-5L), Before start of radiation therapy, at 2,5 years; 5 years 7,5 years, 10 years and 12,5 years after completion of radiation therapy.|Cognition, Patient-rated cognition is measured with the Groninger Cognitionlist (GroCo), Before start of radiation therapy, at 2,5 years; 5 years 7,5 years, 10 years and 12,5 years after completion of radiation therapy.|Cognition, Cognition measured with the Rey's auditory verbal learning test, Before start of radiation therapy, at 2,5 years; 5 years 7,5 years, 10 years and 12,5 years after completion of radiation therapy.|Cognition, Cognition measured with the Doors test, Before start of radiation therapy, at 2,5 years; 5 years 7,5 years, 10 years and 12,5 years after completion of radiation therapy.|Cognition, Cognition measured with the Semantic fluency test, Before start of radiation therapy, at 2,5 years; 5 years 7,5 years, 10 years and 12,5 years after completion of radiation therapy.|Cognition, Cognition measured with the Boston naming test, Before start of radiation therapy, at 2,5 years; 5 years 7,5 years, 10 years and 12,5 years after completion of radiation therapy.|Cognition, Cognition measured with the Controlled oral word association test, Before start of radiation therapy, at 2,5 years; 5 years 7,5 years, 10 years and 12,5 years after completion of radiation therapy.|Cognition, Cognition measured with the Trail making test, Before start of radiation therapy, at 2,5 years; 5 years 7,5 years, 10 years and 12,5 years after completion of radiation therapy.|Cognition, Cognition measured with the Digit span test, Before start of radiation therapy, at 2,5 years; 5 years 7,5 years, 10 years and 12,5 years after completion of radiation therapy.|Cognition, Cognition measured with the Symbol digit modality test, Before start of radiation therapy, at 2,5 years; 5 years 7,5 years, 10 years and 12,5 years after completion of radiation therapy.|Cognition, Cognition measured with the Vienna test system test, Before start of radiation therapy, at 2,5 years; 5 years 7,5 years, 10 years and 12,5 years after completion of radiation therapy.|Cognition, Cognition measured with the FEEST test, Before start of radiation therapy, at 2,5 years; 5 years 7,5 years, 10 years and 12,5 years after completion of radiation therapy.|Cognition, Cognition measured with the Key search test, Before start of radiation therapy, at 2,5 years; 5 years 7,5 years, 10 years and 12,5 years after completion of radiation therapy.|Cognition, Cognition measured with the Zoo map test, Before start of radiation therapy, at 2,5 years; 5 years 7,5 years, 10 years and 12,5 years after completion of radiation therapy.