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

NCT06528912 | Recruiting

• 1 other identifier: SFP Neuro-Oncology
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurological Cancer

Keywords

Acute toxicity; Late toxicity; Prediction models

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

  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

  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 (16)

• Patient-rated Quality of Life

  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

  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

  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.

Interventions

Radiotherapy OTHER

Follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

neuro-oncology patients

You may qualify if:

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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

UMCG

Groningen, 9713GZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Central Nervous System Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Hiske vd Weide

CONTACT

050-3615632; h.l.van.der.weide@umcg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: July 30, 2024
• Study Start: December 1, 2017
• Primary Completion (Estimated): January 1, 2040
• Study Completion (Estimated): January 1, 2040
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

NL (1)