Identification of the genetic pathways involved in patients overreacting to radiotherapy - GENEPI II

MAASTRO clinic0 个研究点目标入组 6 人开始时间: 待定最近更新: 2024年6月18日

适应症

试验速览

暂无简介。

•--Overreacting patients: severe acute or late side effects after radiotherapy without concurrent chemotherapy or *biologicals* (e.g. interferon), *targeted drugs* (e.g. EGFR or VEGF inhibitors) or radio-protectors (e.g. amifostine).
•Neo-adjuvant or adjuvant systemic treatment (e.g. chemotherapy, targeted agents) is thus allowed, as long as they are not given concurrently with radiotherapy.
•*Severe acute side effects:
•. CTCAE 3.0 grade 2 or more occurring at very low radiation doses where these side effects are unexpected
•. CTCAE 3.0 grade 3-4 lasting more than 4 weeks after the end of radiotherapy and/ or requiring surgical intervention at any time.
•* Severe late side effects:
•.CTCAE 3.0 grade 3-4 occurring or persisting more than 90 days after the end of radiotherapy.
•-Knowledge of the dose distribution known, making it clear that the adverse reaction was not due to radiotherapy technique or overdose.;-Concomitant medications at the time of radiotherapy known.
•-No known hereditary syndromes that increase radio-sensitivity (see list Exclusion criteria.*).
•-Medical conditions that may influence the response to radiation known (systemic lupus erythematosus, scleroderma, rheumatoid arthritis)
•-Neo- or adjuvant chemotherapy or other drugs known.
•-Concomitant co-morbidities known: diabetes mellitus, COPD, Crohn*s disease, colitis, *

•- Concurrent radiotherapy with
•. Chemotherapy,
•. *Biologicals* (e.g. interferon),
•. *Targeted drugs* (e.g. EGFR or VEGF inhibitors) or
•. Radio-protectors (e.g. amifostine).
•- Thorough knowledge of the dose distribution at least in 2D not known, even after re-calculation.
•- Concomitant medications at the time of radiotherapy not known.
•- Known hereditary syndromes that increase radio-sensitivity such as (2,3,7-11)
•. Ataxia telangiectasia,
•. The Nijmegen Breakage Syndrome,
•. Fanconi*s anemia,
•. The Li Fraumeni syndrome,
•. Cockayne*s syndrome

发起方