NCT07125755招募中3 期
A Prospective, Multicenter, Randomized Controlled Phase 3 Clinical Trial Comparing Postoperative Adjuvant Cisplatin Concurrent Chemoradiotherapy With Adjuvant Radiotherapy Alone for Intermediate-risk Head and Neck Squamous Cell Carcinoma
Sun Yat-sen University6 个研究点 分布在 1 个国家目标入组 386 人开始时间: 2025年8月15日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 386
- 试验地点
- 6
- 主要终点
- Failure-free survival (FFS)
研究概览
简要总结
The main objective of this trial was to determine the value of concurrent chemoradiotherapy for Intermediate-risk head and neck squamous cell carcinoma
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
- Double (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
- •A. The pathological type is head and neck squamous cell carcinoma
- •B. Radical surgery has been performed, and there are intermediary-risk factors (pT3/pT4, pN2/pN3, positive lymph nodes in the cervical IV/V region of oral cancer, nerve invasion, and vascular invasion).
- •C. No evidence of distant metastasis (M0).
- •D. Functional status: Karnofsky scale (KPS) >
- •E. Normal bone marrow function:
- •white blood cell count > 4×109/L
- •hemoglobin > 120g/L in males, 110g/L in females
- •platelet count > 100×109/L
- •G. Normal liver function:
- •alanine aminotransferase (ALT), aspartate aminotransferase (AST) < 1.5 times the upper limit of normal (ULN)
- •alkaline phosphatase (ALP) < 2.5×ULN
- •bilirubin < ULN.
- •H. Normal renal function: creatinine clearance > 60 ml/min.
- •I. Patients must be informed of the basic contents of this study and sign informed consent.
排除标准
- •A. Age >70 years or <18 years.
- •B. Treatment is palliative.
- •C. Previous chemotherapy (except induction chemotherapy prior to surgery).
- •D. Previous radiation therapy.
- •E. Women who are pregnant or breastfeeding
- •F. Previous history of malignant tumor.
- •G. With other serious medical conditions that may pose a greater risk or affect compliance with the test. Examples include:
- •unstable heart disease that requires treatment
- •kidney disease
- •chronic hepatitis
- •poorly controlled diabetes (fasting blood glucose > 1.5×ULN)
- •mental illness.
研究组 & 干预措施
2 courses of cisplatin chemoradiotherapy arm
Experimental
Patients will receive intensity modulated radiotherapy (total dose: > 66 Gy, split dose: 2-2.2 Gy/ time, once a day, 5 times a week) plus concurrent Cisplatin chemotherapy (100 mg/m2 intravenous injection,once every 3 weeks, twice in total, on days 1 and 22).
干预措施: Cisplatin (Drug)
结局指标
主要结局
Failure-free survival (FFS)
时间窗: 3 years
calculated from enrolment to the date of locoregional recurrence,distant metastasis,or death from any cause, whichever occurred first.
次要结局
- Overall survival (OS)(3 years)
- Distant metastasis-free survival(DMFS)(3 years)
- locoregional recurrence-free survival (LRRFS)(3 years)
- Quality of life (QoL)(3 years)
研究者
Lei Chen
Clinical Professor
Sun Yat-sen University
研究点 (6)
Loading locations...
相似试验
已完成
3 期
Radiotherapy or Imiquimod in Complex Lentigo MalignaLentigo MalignaNCT02394132Melanoma and Skin Cancer Trials Limited126
Unknown
2 期
Clinical Randomized Study of Concurrent Chemo-radiotherapy vs Radiotherapy Alone to Local-advanced Small Cell Lung Cancer (SCLC)Small Cell Lung CancerNCT01745445Tianjin Medical University Cancer Institute and Hospital30
尚未招募
不适用
A Multicenter Randomized Controlled Clinical Study on the Treatment of T3N1M0 High Risk Nasopharyngeal Carcinoma With or Without Induction Chemotherapy Before Concurrent Radiotherapy and ChemotherapyNasopharyngeal CarcinomaNCT05622474Sun Yat-sen University236
已完成
3 期
Concurrent Cisplatin Chemoradiation With or Without Capecitabine as Adjuvant Chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma: Randomized Control Clinical TrialLocal Advanced High Risk Nasopharyngeal CarcinomaNCT02143388Zhao Chong180
Unknown
2 期
CCRT With Itraconazole in Locally Advanced Squamous Esophageal CancerEsophageal NeoplasmEsophageal DiseasesEsophageal Squamous Cell CarcinomaNCT04481100Hangzhou Cancer Hospital38