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Clinical Trials/NCT06528912
NCT06528912RecruitingNot Applicable

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

University Medical Center Groningen1 site in 1 country10,000 target enrollmentStarted: December 1, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
10,000
Locations
1
Primary Endpoint
Radionecrosis

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Radionecrosis

Time Frame: 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

Time Frame: 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 Outcomes

  • 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)
  • 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.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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