NCT03401840已完成不适用
A Multicenter Prospective Phase II Study of Postoperative Hypofractionated Stereotactic Body Radiotherapy (SBRT) in the Treatment of Early Stage Oropharyngeal and Oral Cavity Cancers with High Risk Margins.
Centre Jean Perrin24 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年1月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 24
- 主要终点
- severe late toxicity
研究概览
简要总结
The main objective of this national, open-label, non-randomized phase II trial is to evaluate severe late toxicity of postoperative hypofractionated stereotactic radiotherapy (SBRT) in the treatment of early stage oropharyngeal and oral cavity cancer with high risk margins.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Operated squamous cell carcinoma of oral cavity (lips excepted) or oropharynx
- •pT1 or pT2 ((UICC 7th edition 2009)
- •Indication of postoperative tumor site irradiation (retained in multidisciplinary tumor board) with at least one of the following criteria :
- •positive R1 margin (re-resection not proposed)
- •close margin < 5 mm (re-resection not proposed)
- •Margin estimated at risk, with uncertain pathological margin (re-resection not proposed)
- •N0 after surgical management of the neck (neck dissection or sentinel lymph node biopsy) or pN1 without extracapsular extension (carcinological neck dissection)
- •Age ≥ 18 years
- •ECOG status ≤ 2
- •Written signed informed consent before any specific procedure of the protocol
- •Affiliation to a social security scheme or beneficiary of such a scheme
排除标准
- •Other histology than squamous cell carcinoma
- •pT3 or pT4
- •pT2>3cm and R1 with concurrent chemoradiotherapy decided in multidisciplinary tumor board
- •Lymphovascular invasion justifying neck irradiation
- •Neck irradiation decided in multidisciplinary tumor board
- •Lack of at least one of the following elements :
- •pre-operative medical imaging (CT scan or MRI)
- •endoscopy report
- •surgery report
- •pathological report
- •Prior radiotherapy to the head and neck area
- •Distant metastasis
- •Pregnant or nursing (lactating) woman
- •women or men of childbearing age not taking adequate contraceptive measure
- •participation in another investigational study within 4 weeks prior to inclusion
- •History of other malignancy within 5 years prior enrollment except for basal cell carcinoma of the skin or carcinoma in situ of the cervix
- •Persons deprived of their liberty, under guardianship or curatorship, or unable to follow the trial for geographical, social or psychological reasons
结局指标
主要结局
severe late toxicity
时间窗: from 3 months to 2 years following the end of radiotherapy
2-year toxicity of grade ≥ 3 related to SBRT according to CTCAE V4.03 classification.
次要结局
- Overall survival (OS)(2 years following the end of radiotherapy)
- Local control(2 years following the end of radiotherapy)
- Locoregional control(2 years following the end of radiotherapy)
- Quality of life (global evaluation)(at baseline, 1 month, 1 year and 2 years post radiotherapy)
- Acute toxicity(from the first fraction to 3 months after the end of radiotherapy)
- disease free survival (DFS)(2 years following the end of radiotherapy)
- Quality of life (specific evaluation for Head and Neck Cancer)(at baseline, 1 month, 1 year and 2 years post radiotherapy)
- Nutritional impact(during 2 years following the end of radiotherapy)
- Nutritional support(during 2 years following the end of radiotherapy)
- Predictive factors of toxicity(2 years following the end of radiotherapy)
研究者
研究点 (24)
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