NCT02442375已完成3 期
Uniform 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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 5
- 主要终点
- Toxicity: normalcy of diet (score of the performance status scale for head and neck cancer patients)
研究概览
简要总结
The objective of the UPGRADE-RT trial is to investigate whether de-escalation of elective radiation dose and introduction of an intermediate dose-level in the treatment of head and neck cancer will results in less radiation sequelae and improved quality of life after treatment whilst the recurrence rate in electively irradiated lymph nodes should not be compromised.
The full study protocol can be found here:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed tumours classified as stage T2-4 N0-2 (TNM 7th edition 2009) located in the larynx, oropharynx or hypopharynx (unknown primary and oral cavity are not eligible)
- •Histopathological diagnosis of invasive squamous cell carcinoma in the primary tumour
- •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.
- •Radiotherapy planned to start within 6 weeks from baseline imaging of tumour assessment
- •No distant metastasis (M0) (TNM 7th edition 2009)
- •WHO performance status 0-2
- •≥ 18 years of age
- •Written informed consent
排除标准
- •Concomitant chemotherapy or EGFR inhibitors for this tumour.
- •Primary tumour of the oral cavity or unknown primary tumour
- •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.
- •Current participation in any other oncologic interventional clinical study for this tumor.
- •Uncontrolled diabetes mellitus.
- •Known or suspected HIV infection.
- •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, basal/squamous cell carcinoma of the skin, and other non-invasive malignancies (e.g. in situ carcinomas)..
- •Any condition (somatic, psychological, familial, sociological or geographical) rendering the patient unable to understand or complete questionnaires.
结局指标
主要结局
Toxicity: normalcy of diet (score of the performance status scale for head and neck cancer patients)
时间窗: 12 months
次要结局
- Safety: recurrence in electively irradiated lymph nodes(24 months)
研究者
研究点 (5)
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