Evaluation of the Automatic Deformable Recontouring on the Daily MVCT for Head and Neck Cancer Adaptive Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Rate of patients with Dice Similarity Coefficient (DSC) of the volumes of left and right parotid gland superior to 0.85 (DSC > 0.85)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •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.
排除标准
- •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
研究组 & 干预措施
Radiotherapy treatment
干预措施: Helical intensity-modulated radiotherapy (IMRT) (Other)
结局指标
主要结局
Rate of patients with Dice Similarity Coefficient (DSC) of the volumes of left and right parotid gland superior to 0.85 (DSC > 0.85)
时间窗: 7 weeks for each patient
次要结局
- Rate of patients with DSC > 0.85 for other organs at risk (oral cavity, medullar canal, mandible,brain stem, larynx)(7 weeks for each patient)
- Rate of patients with DSC > 0.85 for target volumes (clinical target volume, gross target volume, planning target volume)(7 weeks for each patient)
- Time saving defined by the difference between standard recontouring time (manuel recontouring) and experimental recontouring time (Precise ART™ or Precise RTX™)(7 weeks for each patient)