NL-OMON35606已完成不适用
Identification of the genetic pathways involved in patients overreacting to radiotherapy - GENEPI II
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •--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, *
排除标准
- •- 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
研究者
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