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Spots Global Cancer Trial Database for Short Term Outcomes After PRoton And photoN radiOtherapy for IDH Mutated Grade 2 and 3 Gliomas

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Trial Identification

Brief Title: Short Term Outcomes After PRoton And photoN radiOtherapy for IDH Mutated Grade 2 and 3 Gliomas

Official Title: Short Term Outcomes After PRoton And photoN radiOtherapy for IDH Mutated Grade 2 and 3 Gliomas

Study ID: NCT06180434

Interventions

Study Description

Brief Summary: Rationale: Proton beam therapy has recently become available for the treatment of patients with WHO grade 2 and 3 IDH mutated (IDHmt) glioma in the Netherlands. The dose distributions associated with proton therapy have substantially reduced the volume of the normal brain irradiated with low and intermediate radiotherapy doses. Whether this impacts rates of progressive disease or safety issues and how this compares with a similar population treated with photon therapy is currently unknown. Objective: To investigate short term outcomes after proton and photon radiotherapy for grade 2 and 3 IDHmt glioma.

Detailed Description: Patients with grade 2 and 3 IDHmt glioma treated with proton therapy in Holland PTC, Maastro and UMC Groningen and referred Erasmus MC, Haaglanden MC, LUMC, Amsterdam UMC, Verbeeten Institute, Maastro, UMC Groningen, and Leuven University Hospital between 1st of January 2018 and the 30th of June 2022. The outcomes will be compared to those from patients with grade 2 and 3 IDHmt glioma treated with photon therapy in the same institutes and during the same period of time. The applied clinical target volume (CTV) margins and the chemotherapy are preferably similar for proton and photon therapy. Retrospective data will be collected from the electronic records of each participating institute. For the primary outcome, data will be collected on interventions (radiotherapy, surgery, chemotherapy, medication) for either tumor progression or toxicity after radiotherapy. This will be used to calculate next intervention free survival as primary outcome. For the secondary outcomes, data on survival, disease progression, pseudoprogression, and toxicity will be used to calculate overall survival, progression free survival, and pseudoprogression free survival, as well as toxicity incidence.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Name: Alejandra Mendez Romero, MD PhD

Affiliation: Assitant Professor, Radiation Oncologist

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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