Artificial Intelligence Empowered Online Adaptive Radiotherapy Versus Conventional Radiotherapy in Non-metastatic Nasopharyngeal Carcinoma: an Open-label, Non-inferiority, Multicentre, Randomised Phase 3 Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 494
- 试验地点
- 1
- 主要终点
- Locoregional recurrence-free survival
研究概览
简要总结
In this multicenter, prospective, randomized, controlled, non-inferiority Phase III clinical trial, treatment-naïve patients with nasopharyngeal carcinoma (NPC) without metastasis will be enrolled for curative radiotherapy. The participants will be randomly assigned to two groups. The experimental group will receive online adaptive radiotherapy (ART) during the radiotherapy process, with a smaller PTV margin, while the control group will use original treatment plan during full-course radiotherapy, with a PTV margin of 3 mm. The study aims to compare the survival, adverse events, and quality of survival between the two groups, with the primary endpoint being the locoregional recurrence-free survival rate. The main objective is to determine the role of online ART in nasopharyngeal carcinoma, elucidating its potential to alleviate radiation toxicity in patients while ensuring treatment efficacy.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed nasopharyngeal carcinoma confirmed by pathology, with a histological classification of non-keratinizing carcinoma (according to the World Health Organization, WHO), pathological classification.
- •No evidence of distant metastasis (M0).
- •Age between 18 and 70 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status score:0-
- •Undergoing radical intensity-modulated radiation therapy (IMRT).
- •No claustrophobia and able to remain in a fixed position for at least 30 minutes
- •Patients must be informed of the main content of this study, sign an informed consent form, and be willing and able to comply with the treatment, follow-up plan, laboratory tests, and other requirements specified in the study protocol.
排除标准
- •Histological types include squamous cell carcinoma or basal cell carcinoma.
- •Radiation therapy intended for palliative care.
- •History of malignant tumors, excluding adequately treated basal cell carcinoma, squamous cell carcinoma, and cervical intraepithelial neoplasia.
- •Pregnant or lactating women (women of childbearing age should undergo pregnancy testing; effective contraception should be emphasized during treatment.
- •Previous radical radiotherapy for nasopharyngeal cancer.
- •Primary and neck metastatic lesions treated with chemotherapy or surgery.
- •Presence of other serious underlying diseases that may pose a greater risk or affect compliance with the trial. Examples include unstable cardiac diseases requiring treatment, renal diseases, chronic hepatitis, poorly controlled diabetes (fasting blood glucose > 1.5×ULN), and psychiatric disorders.
- •Initial assessment of treatment efficacy more than 120 days after the end of radiotherapy.
- •Inability to undergo enhanced magnetic resonance imaging due to contrast agent allergies, claustrophobia.
研究组 & 干预措施
Conventional radiotherapy with conventional margins w or w/o chemotherapy
Complete the full course of radiotherapy using the original treatment plan. PTV margin: 3mm.
干预措施: Intensity modulated radiation therapy (IMRT) with conventional planning target volume (PTV) margin and without online adaptive radiotherapy (Radiation)
Conventional radiotherapy with conventional margins w or w/o chemotherapy
Complete the full course of radiotherapy using the original treatment plan. PTV margin: 3mm.
干预措施: Chemotherapy (Drug)
Radiotherapy with smaller margin and online adaptive radiotherapy w or w/o chemotherapy
Throughout the course of radiotherapy, the treatment plan is adjusted online based on the anatomical and dosimetric changes in the target volumes and organs at risk of the patients.
PTV margin: smaller.
干预措施: Intensity modulated radiation therapy (IMRT) with smaller planning target volume (PTV) margin and online adaptive radiotherapy (Radiation)
Radiotherapy with smaller margin and online adaptive radiotherapy w or w/o chemotherapy
Throughout the course of radiotherapy, the treatment plan is adjusted online based on the anatomical and dosimetric changes in the target volumes and organs at risk of the patients.
PTV margin: smaller.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Locoregional recurrence-free survival
时间窗: 3-year
locoregional progression free survival
次要结局
- Rate of acute radiation-induced events according to Common Terminology Criteria for Adverse Events (CTCAE 5.0)(3 months)
- Distant metastasis free survival(3-year)
- Rate of late radiation-induced events according to Common Terminology Criteria for Adverse Events (CTCAE 5.0).(3-year)
- European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck 35 Version 1.0 (EORTC QLQ-HN35 V1.0)(From baseline to 3 years post-radiotherapy)
- and National Cancer Institute Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events Version 1.0 (NCI-PRO-CTCAE V1.0.)(From baseline to 3 years post-radiotherapy)
- Overall survival(3-year)
研究者
YingSun
Principal Investigator
Sun Yat-sen University