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

Recruiting

• Conditions: Neurological Cancer

• Registration Number: NCT06528912
• Lead Sponsor: University Medical Center Groningen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2024-02-26
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-29
• Last Update Submitted: 2024-07-29
• Study First Posted: 2024-07-30
• Last Update Posted: 2024-07-30
• Primary Completion: 2040-01
• Study Completion: 2040-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Radionecrosis	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.	Treatment associated radionecrosos measured with CTCAE
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.	Treatment associated CNS Toxicity

Secondary Outcome Measures

Name	Time	Method
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	Progression free survival
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	Treatment associated non-CNS toxicity
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.	Overall survival

Trial Locations

Locations (1)

UMCG; 🇳🇱 Groningen, Netherlands