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NCT Number: NCT06528912

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

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.

Recruiting

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Key information

Conditions

Neurological Cancer Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiotherapy

Other

Follow-up

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Treatment associated non-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 non-CNS toxicity

  2. Overall survival

    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.

    Overall survival

  3. Progression free survival

    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

    Progression free survival

Other outcomes

  1. Patient-rated Quality of Life

    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.

    Patient-rated quality of Life is measured with the Quality-of-Life Questionnaire-C30 (EORTC QLQ-C30)

  2. Patient-rated Quality of Life

    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.

    Patient-rated quality of Life is measured with the Quality-of-Life Questionnaire Brain Cancer module (EORTC QLQ-BN20)

  3. Patient-rated Quality of Life

    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.

    Patient-rated quality of Life is measured with the EuroQol Health questionnaire 5-level version (EuroQoL-5D-5L)

  4. Cognition

    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.

    Patient-rated cognition is measured with the Groninger Cognitionlist (GroCo)

  5. Cognition

    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.

    Cognition measured with the Rey's auditory verbal learning test

  6. Cognition

    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.

    Cognition measured with the Doors test

  7. Cognition

    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.

    Cognition measured with the Semantic fluency test

  8. Cognition

    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.

    Cognition measured with the Boston naming test

  9. Cognition

    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.

    Cognition measured with the Controlled oral word association test

  10. Cognition

    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.

    Cognition measured with the Trail making test

  11. Cognition

    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.

    Cognition measured with the Digit span test

  12. Cognition

    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.

    Cognition measured with the Symbol digit modality test

  13. Cognition

    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.

    Cognition measured with the Vienna test system test

  14. Cognition

    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.

    Cognition measured with the FEEST test

  15. Cognition

    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.

    Cognition measured with the Key search test

  16. Cognition

    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.

    Cognition measured with the Zoo map test

Study contacts

Contact information is provided by the study sponsor or research team.

Hiske vd Weide

CONTACT

[email protected]

050-3615632

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2040
Study completion
2040
First posted
Jul 30, 2024
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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