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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neurological Cancer
• Intervention / Treatment: Other: Radiotherapy

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Hiske vd Weide; Phone Number: 050-3615632; Email: h.l.van.der.weide@umcg.nl

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713GZ
    • Recruiting
    • UMCG
    • Contact: Hiske vd Weide; Phone Number: 050-3615632; Email: h.l.van.der.weide@umcg.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

neuro-oncology patients

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Estimated): January 1, 2040
• Study Completion (Estimated): January 1, 2040

Study Registration Dates

• First Submitted: February 26, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Acute toxicity; Late toxicity; Prediction models
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms; Neoplasms by Site; Nervous System Neoplasms; Central Nervous System Neoplasms
• Other Study ID Numbers: SFP Neuro-Oncology

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No