Clinical trial NCT06528912: Standard Follow-up Program Neuro-oncology Patients (SFP Neuro-Oncology)
Official title: Standard Follow-up Program (SFP) for Neuro-oncology Cancer Patients Treated With Radiotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neurological Cancer
Keywords: Acute toxicity
Late toxicity
Prediction models
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: neuro-oncology patients

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Patient with neuro-oncological cancer
* Patient receiving a radiotherapy dose XXX Gy

Exclusion Criteria:

* Failure to comply with any of the inclusion criteria

Primary outcomes:
measure: Treatment associated CNS toxicity
timeFrame: 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.
measure: Radionecrosis
timeFrame: 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:
measure: Treatment associated non-CNS toxicity
timeFrame: 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
measure: Overall survival
timeFrame: 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.
measure: Progression free survival
timeFrame: 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 outcomes:
measure: Patient-rated Quality of Life
timeFrame: 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.
measure: Patient-rated Quality of Life
timeFrame: 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.
measure: Patient-rated Quality of Life
timeFrame: 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.
measure: Cognition
timeFrame: 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.
measure: Cognition
timeFrame: 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.
measure: Cognition
timeFrame: 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.
measure: Cognition
timeFrame: 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.
measure: Cognition
timeFrame: 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.
measure: Cognition
timeFrame: 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.
measure: Cognition
timeFrame: 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.
measure: Cognition
timeFrame: 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.
measure: Cognition
timeFrame: 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.
measure: Cognition
timeFrame: 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.
measure: Cognition
timeFrame: 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.
measure: Cognition
timeFrame: 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.
measure: Cognition
timeFrame: 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.
Locations:
city: Groningen
country: Netherlands
facility: UMCG
Study officials:
References: