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Standard Follow-up Program Neuro-oncology Patients (SFP Neuro-Oncology)

Standard Follow-up Program (SFP) for Neuro-oncology Cancer Patients Treated With Radiotherapy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06528912
Enrollment
10000
Registered
2024-07-30
Start date
2017-12-01
Completion date
2040-01-31
Last updated
2024-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurological Cancer

Keywords

Acute toxicity, Late toxicity, Prediction models

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.

Interventions

OTHERRadiotherapy

Follow-up

Sponsors

University Medical Center Groningen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Treatment associated CNS toxicityBefore start of radiation therapy, at 2,5 years; 5 years 7,5 years, 10 years and 12,5 years after completion of radiation therapy.Treatment associated CNS Toxicity
RadionecrosisBefore start of radiation therapy, at 2,5 years; 5 years 7,5 years, 10 years and 12,5 years after completion of radiation therapy.Treatment associated radionecrosos measured with CTCAE

Secondary

MeasureTime frameDescription
Progression free survivalBefore start of radiation therapy, at 2,5 years; 5 years 7,5 years, 10 years and 12,5 years after completion of radiation therapyProgression free survival
Overall survivalBefore 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
Treatment associated non-CNS toxicityBefore start of radiation therapy, at 2,5 years; 5 years 7,5 years, 10 years and 12,5 years after completion of radiation therapyTreatment associated non-CNS toxicity

Other

MeasureTime frameDescription
Patient-rated Quality of LifeBefore 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 is measured with the Quality-of-Life Questionnaire-C30 (EORTC QLQ-C30)
CognitionBefore 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 cognition is measured with the Groninger Cognitionlist (GroCo)

Countries

Netherlands

Contacts

Primary ContactHiske vd Weide
h.l.van.der.weide@umcg.nl050-3615632

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026