NCT05994170招募中不适用
Reducing High Risk Primary Tumor Clinical Target Volumes (CTVp1) in Non-metastatic Nasopharyngeal Carcinoma Treated With Intensity-modulated Radiotherapy(IMRT): A Phase 3, Multicentre, Randomised Controlled Trial(CTVp1-NPC)
Zhongshan People's Hospital, Guangdong, China1 个研究点 分布在 1 个国家目标入组 454 人开始时间: 2023年8月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 454
- 试验地点
- 1
- 主要终点
- Local Relapse-free Survival(LRFS)
研究概览
简要总结
To evaluate the long-term local control, survival rate, acute and late radiation related toxicities, quality of life after reducing high risk primary tumor clinical target volumes (CTVp1) in non-metastatic nasopharyngeal carcinoma treated with IMRT.
详细描述
This phase 3, multicenter,randomized controlled clinical trial recruits patients with newly-diagnosed non-metastatic nasopharyngeal carcinoma patients treated with IMRT. The intervention is delineating high risk primary tumor clinical target volumes (CTVp1) as GTV+5mm or GTV+5mm+whole nasopharynx. The objective is to compare the long-term local control, survival rate, acute and late radiation related toxicities between the two groups.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •histologic confirmation of nonkeratinizing nasopharyngeal carcinoma(WHO II-III);
- •newly diagnosed stage I to IVa according to the American Joint Committee on Cancer-Union for International Cancer Control 8th edition stage-classification system
- •nasopharyngeal mass confined to one side of nasopharynx and did not exceed the midline(the line between the nasal septum and the midpoint of spinal cord/medulla) detected by electronic nasopharyngoscope (ENS) and magnetic resonance imaging (MRI). Pathological biopsy was recommended if it was unclear whether tumor invaded the contralateral side radiographically.
- •planned to receive curative IMRT, Chemotherapy drugs should be administered according to Chinese Society of Clinical Oncology (CSCO) guidelines depending on the TNM stage;(T1N0: No chemotherapy required;T2N0：No chemotherapy or concurrent cisplatin chemoradiotherapy if there are adverse prognostic indicators such as Epstein-Barr virus (EBV) DNA>4000 copies，node >3cm or with extranodal extension;T1-2N1: concurrent cisplatin chemoradiotherapy;T3N0: concurrent cisplatin chemoradiotherapy; stage III-Iva: platinum-based neoadjuvant chemotherapy+ concurrent cisplatin chemoradiotherapy+/-metronomic capecitabine therapy )
- •no previous treatment for cancer；
- •a Karnofsky performance-status score of at least 70 (on a scale from 0 to 100, with lower scores indicating greater disability);
- •between 18 and 70 years old;
- •adequate hematologic, renal, and hepatic function: Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L;Adequate liver function: ALT and AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;Adequate renal function: BUN and CRE ≤ 1.5×ULN , endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
- •Patients must be informed of the investigational nature of this study and give written informed consent.
排除标准
- •receipt of treatment with palliative intent;
- •receipt of previous treatment (radiotherapy, chemotherapy, or surgery [except diagnostic procedures]) to the nasopharynx;
- •had disease progress after neoadjuvant chemotherapy in local advantage NPC
- •presence of distant metastasis;
- •Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma;
- •Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma;
- •Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment;
- •lactation or pregnancy;
- •Any other condition including Mental disorder,drug or alcohol addition;do not have full capacity for civil acts.
结局指标
主要结局
Local Relapse-free Survival(LRFS)
时间窗: 3 years
the time from randomization to documented local recurrence or death from any cause
Incidence of hearing impairment worse than graded 2
时间窗: 3 years
audiometry and symptoms graded according to the CTCAE (version 5.0).
次要结局
- Acute toxicities(3 months)
- Overall survival (OS)(3 years)
- Regional Relapse-free Survival(RRFS)(3 years)
- Distant metastasis-free survival (DMFS)(3 years)
- Late toxicities(3 years)
- Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-H&N35)(3 years)
- radiation-induced otitis media with effusion (OME)(3 years)
- Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-C30)(3 years)
- V60Gy(3 years)
研究者
Gui-Qiong Xu
Clinical Professor
Zhongshan People's Hospital, Guangdong, China
研究点 (1)
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