NL-OMON44880已完成3 期
niform FDG-PET guided gradient dose prescription to reduce late radiation toxicity (UPGRADE RT): a randomised controlled trial with dose reduction to the elective neck in head and neck squamous cell carcinoma - UPGRADE-RT
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1) Newly diagnosed tumours classified as stage T2-4 N0-2 located in the larynx, oropharynx or hypopharynx (unknown primary and oral cavity are not eligible)
- •2) Histopathological diagnosis of invasive squamous cell carcinoma in the primary tumour
- •3) Decision for curative intent external beam radiotherapy with elective treatment of the neck made by a multidisciplinary head-and-neck oncology team. The patient must be expected to complete the treatment.
- •4) Radiotherapy planned to start within 6 weeks from baseline imaging of tumour assessment
- •5) No distant metastasis (M0)
- •6) WHO performance status 0-2
- •7) >= 18 years of age
- •8) Written informed consent
排除标准
- •1) Concomitant chemotherapy or EGFR inhibitors for this tumour.
- •2) Prior or current anticancer treatment to the head and neck area (e.g. radical attempted or tumour reductive surgery, neo-adjuvant or concomitant chemotherapy, EGFR inhibitors or radiotherapy), except for endoscopic glottic laser micro surgery.
- •3) Current participation in any other interventional clinical study.
- •4) Uncontrolled diabetes mellitus.
- •5) Known or suspected HIV infection.
- •6) History of previous malignancy within the last 3 years, with the exception of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal/squamous cell carcinoma of the skin.
- •7) Any condition (somatic, psychological, familial, sociological or geographical) rendering the patient unable to understand or complete questionnaires.
研究者
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