Phase II Randomized Trial of RT-Led Daily Adaptive Radiotherapy for Submandibular Gland-Sparing in Head and Neck Cancer (RTL-DART)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in saliva production
研究概览
简要总结
This is a randomized, single centre, single blinded prospective study comparing the standard of care imaging guided radiation therapy and daily adaptive radiotherapy (ART) for submandibular gland-sparing in head and neck cancer
详细描述
This study will recruit up to 50 patients planned to receive curative (chemo) radiotherapy for (head and neck squamous cell carcinoma) HNSCC with at least one level 1b lesion not being treated electively and with no high dose structure <1cm to spared (submandibular gland) SMG. The effect of daily ART with SMG dose sparing will be studied using both doimetric analysis and externally-validated quantitative metrics of unstimulated salivary flow as an object assessment for submandibular gland function. Patient report outcomes will assess the effect of the intervention on self-reported quality of life following treatment.
Patients, at the time of enrollment, will be randomized into one of the two treatment arms. The patients will be blinded to prevent bias in their quality of life assessments.
Patients in both arms will undergo a baseline functional CT scan along with other assessments including oral and dental assessment, PSS-HNC swallow assessment, unstimulated salivary flow rate test, DMFS160 index, and quality of life questionnaire. The radiation treatment will take approximately 7 weeks to complete. The follow up visits will be at 1.5, 6, 12, and 24 months with assessments similar to baseline.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Histologically proven Squamous Cell carcinoma of head and neck
- •Bilateral neck being treated
- •At least one level 1b not being treated electively and with no target structure, other than elective level II/III, <1cm to spared SMG
- •ECOG PS 0-2
- •Planned for curative (chemo)radiotherapy
- •Able to receive and understand verbal and written information regarding study and able to give written informed consent
- •Be able to lie comfortably on back and to wear immobilization for up to 1 hour
排除标准
- •As judged by investigator evidence of systemic disease that makes unsuitable for study
- •Pregnancy
- •Underlying salivary dysfunction prior to treatment judged by investigator to affect likelihood of benefit from ART
研究组 & 干预措施
Image guided radiation therapy
This arm will proceed as per the standard of care. The pre-treatment reference plan will be delivered daily for 35 fractions. If a notable change in anatomy is identified, a dose of the day calculation may be performed as per current standard head and neck workflow
干预措施: Image guided radiation therapy (Radiation)
Daily Adaptive Radiation Therapy
Structures of daily adaptive radiation therapy organ at risk will be AI generated in the Ethos platform on the daily CBCT and then edited by radiation therapy team as required. A rigid registration of CTV targets to the CBCT replicating the current radiation therapy led IGRT process.
干预措施: Daily adaptive radiation therapy (Radiation)
结局指标
主要结局
Change in saliva production
时间窗: 6 months
Change in saliva production from baseline measured by MST (Malnutrition Screening Test) at 6 months following IGRT or daily ART HN treatment
次要结局
- Change in saliva production(24 months)
- MDADI (MD Anderson Dysphagia Inventory)(24 months)
- Swallow assessment(24 months)
- Toxicity assessment(24 months)
- Comparing dental health between two arms(24 months)
- Procedure delivery comparison(24 months)
- Xerostomia questionnaire(24 months)
- EORTC QLQ HN43 (Quality of Life Questionnaire Head and Neck 43)(24 months)