Evaluation of the Automatic Deformable Recontouring on the Daily MVCT for Head and Neck Cancer Adaptive Radiotherapy (GIRAFE)
This trial is a prospective, monocentric study aiming to evaluate an adaptive radiotherapy method (automatic deformable recontouring on the daily MVCT (MegaVoltage Computerized Tomography)) using the Precise ART™ software in patients with head and neck cancer.
Patients will receive helical intensity-modulated radiotherapy (IMRT) according to the standard recommendations (35 fractions during 7 weeks). Radiotherapy will include daily repositioning MVCT.
For the study, patients will undergo 4 intermediate re-planning CT-scan (without injection of intravenous contrast agent) at week 3, week 4, week 5 and week 6 of treatment.
3 recontouring modalities will be evaluated for the study:
- Manuel recontouring (standard method)
- Precise ART™ deformed contours
- Precise RTX™ deformed contours
The total duration of the study for each patient will be 7 weeks.
研究概览
研究类型
阶段
- 不适用
联系人和位置
学习地点
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Toulouse、法国
- Institut Universitaire Du Cancer Toulouse - Oncopole (Iuct-O)
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age ≥ 18 years old
- Patient with histologically proven locally advanced head and neck cancer (Oropharynx, hypopharynx, larynx, nasopharynx, oral cavity, sinuses, nasal cavities, ethmoid sinus, cavum, salivary glands)
- Cancer with nodal involvement (at least T3 or involved node >2 cm)
- Eastern Cooperative Oncology Group performance status 0 or 1
- No previous curative treatment for head and neck cancer (surgery and/or radiotherapy and/or chemotherapy)
- Indication of exclusive radiotherapy (+/- chemotherapy) validated in multidisciplinary meeting
- Patient affiliated to the french social security system.
- Patient must provide written informed consent prior to inclusion in the study and any study-specific procedure.
Exclusion Criteria:
- Patient with metastatic cancer
- Eastern Cooperative Oncology Group performance status ≥ 2 (due to comorbidities)
- Patient with recurrent disease
- Patient who required urgent surgical treatment
- Contraindications to radiotherapy
- History of cancer within 5 years
- Patient already included in another therapeutic trial
- Pregnant or breastfeeding women
- Any psychological, familial, geographical or sociological condition potentially preventing the medical follow-up and/or study procedures
- Patient protected by law
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Radiotherapy treatment
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Helical intensity-modulated radiotherapy (35 fractions, 5 fractions per week) will be administered during 7 weeks: 2 Gy per fraction on tumor and 1.6 Gy per fraction on bilateral lymph node areas.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Rate of patients with Dice Similarity Coefficient (DSC) of the volumes of left and right parotid gland superior to 0.85 (DSC > 0.85)
大体时间：7 weeks for each patient
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7 weeks for each patient
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Rate of patients with DSC > 0.85 for other organs at risk (oral cavity, medullar canal, mandible,brain stem, larynx)
大体时间：7 weeks for each patient
|
7 weeks for each patient
|
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Rate of patients with DSC > 0.85 for target volumes (clinical target volume, gross target volume, planning target volume)
大体时间：7 weeks for each patient
|
7 weeks for each patient
|
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Time saving defined by the difference between standard recontouring time (manuel recontouring) and experimental recontouring time (Precise ART™ or Precise RTX™)
大体时间：7 weeks for each patient
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7 weeks for each patient
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.