Standard Follow-up Program Neuro-oncology Patients (SFP Neuro-Oncology)
ConditionNeurological Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Medical Center Groningen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient with neuro-oncological cancer
Patient receiving a radiotherapy dose XXX Gy
Disqualifiers
Failure to comply with any of the inclusion criteria
Trial population
neuro-oncology patients
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Radiotherapy
Other interventionFollow-up
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Treatment associated CNS toxicity
Treatment associated CNS Toxicity
Time frame
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.2
Radionecrosis
Treatment associated radionecrosos measured with CTCAE
Time frame
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 outcomes
1
Treatment associated non-CNS toxicity
Treatment associated non-CNS toxicity
Time frame
Before start of radiation therapy, at 2,5 years; 5 years 7,5 years, 10 years and 12,5 years after completion of radiation therapy2
Overall survival
Overall survival
Time frame
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.3
Progression free survival
Progression free survival
Time frame
Before start of radiation therapy, at 2,5 years; 5 years 7,5 years, 10 years and 12,5 years after completion of radiation therapyOther outcomes
1
Patient-rated Quality of Life
Patient-rated quality of Life is measured with the Quality-of-Life Questionnaire-C30 (EORTC QLQ-C30)
Time frame
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.2
Patient-rated Quality of Life
Patient-rated quality of Life is measured with the Quality-of-Life Questionnaire Brain Cancer module (EORTC QLQ-BN20)
Time frame
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.3
Patient-rated Quality of Life
Patient-rated quality of Life is measured with the EuroQol Health questionnaire 5-level version (EuroQoL-5D-5L)
Time frame
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.4
Cognition
Patient-rated cognition is measured with the Groninger Cognitionlist (GroCo)
Time frame
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov