NCT06798922招募中3 期
Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers: a De-escalation Randomized Phase III Trial
Centre Francois Baclesse47 个研究点 分布在 1 个国家目标入组 348 人开始时间: 2025年3月1日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 348
- 试验地点
- 47
- 主要终点
- loco-regional control rate
研究概览
简要总结
Patients with oral cavity cancer treated by reconstructive surgery with a flap.
Patients will be treated in the study for :
- Experimental arm: Post-operative radiotherapy with flap sparing
- Control arm: Standard post-operative radiotherapy without flap sparing (current practice) Radiotherapy by IMRT using photons or proton therapy (IMPT)
详细描述
Patients with oral cavity cancer treated by reconstructive surgery with a flap.
Patients will be treated in the study for :
- Experimental arm: Post-operative radiotherapy with flap sparing
- Control arm: Standard post-operative radiotherapy without flap sparing (current practice) Radiotherapy by IMRT using photons or proton therapy (IMPT) Our purpose is to demonstrate the feasibility of sparing surgical flaps from radiotherapy, in order to reduce toxicity while maintaining local disease control.
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
- 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
- •Patient aged 18 years or older
- •Performance Status 0-2
- •Patient with oral cavity cancer (soft tissue or soft tissue-bone flap), treated by reconstructive surgery with a flap. Oropharynx cancer whose flap extends significantly into the oral cavity may be included in the study
- •Quality of resection with margins > 1 mm
- •Patient candidate to post-operative radiotherapy (Intensity-Modulated Radiation Therapy (IMRT) or proton therapy)
- •Concomitant chemotherapy is allowed (stratification parameter)
- •Patient must have signed a written informed consent form prior to any trial specific procedures
- •Patient affiliated to the social security system
排除标准
- •Local flap (small size limiting IMRT modulation potential)
- •History of radiotherapy of head and neck area
- •Metastatic disease
- •History of other malignancy within the previous 3 years (except for appropriately treated in-situ cervix carcinoma and non-melanoma skin carcinoma)
- •Simultaneous participation in another clinical study may compromise the conduct of this study.
- •Pregnant or lactating women
- •Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
- •Patient deprived of freedom or under guardianship
研究组 & 干预措施
Standard arm
Active Comparator
Standard IMRT or proton therapy practice, usual CTV definition
干预措施: Standard post-operative radiotherapy without flap sparing (current practice) (Radiation)
Experimental arm
Experimental
IMRT or proton therapy with flap sparing
干预措施: Post-operative radiotherapy with flap sparing (Radiation)
结局指标
主要结局
loco-regional control rate
时间窗: 2 years after the end of postoperative radiotherapy
To evaluate whether flap sparing yields non-inferior 2-year loco-regional control rate as flap-agnostic radiotherapy (as per standard routine practice) in completely resected oral cavity carcinomas undergoing postoperative radiotherapy
次要结局
- Proportion of patients with acute and late Ear-Nose-Throat (ENT) toxicities(within 12 months after postoperative radiotherapy)
研究者
研究点 (47)
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