NCT03699969Unknown不适用
A Clinical Study Comparing Hypofractionated Dose Escalated VMAT to Conventional CCRT in Locally Advanced Head and Neck Cancer
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 63
- 主要终点
- Local control in the two arms
研究概览
简要总结
To compare efficacy and toxicity between hypofractionated dose escalated VMAT versus conventional concurrent chemoradiation in locally advanced head and neck cancer
详细描述
patients were randomized to receive either: 70Gy in 35fx in 7wks at 2Gy/fx concurrently with weekly cisplatin 40mg/m2 (Arm A) or 74Gy in 33 fractions (fx) in 6.5 weeks at 2.24Gy/fx (Arm B). Volumetric Modulated Arc Therapy (VMAT) plans were created for both treatment arms
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
- •Age ≥18 years and ≤70 years old.
- •Histopathologically confirmed squamous cell carcinoma of head and neck.
- •Locally advanced tumors (T3-T4 &/or N1-3) (stage IIB, III and stage IV-A: Staging by AJCC 7th edition).
- •Patients not exposed to radical surgery for current disease.
- •Performance status (ECOG) 2 or less.
- •No associated co-morbidity with contraindication to chemotherapy.
- •Normal Hemogram. (ANC ≥1.5x109/L, Platelets count ≥100x109/L, hemoglobin ≥80 g/L)
- •Accepted renal functions. (BUN & serum creatinine <1.5x upper limit of normal value with normal GFR).
- •Accepted liver functions. (total bilirubin and direct bilirubin < 1.5 x ULN & alanine aminotransferase and aspartate aminotransferase < 3 x ULN)
- •Informed consent.
排除标准
- •Patients with distant metastatic lesions, as detected by imaging techniques.
- •Patients with history of other head and neck malignancies.
- •Patients with history of previous head and neck irradiation.
- •Patients with a serious concomitant illness, such as active cardiac disease, severe uncontrolled hypertension, or uncontrolled infection.
- •Women who are pregnant or breast feeding.
研究组 & 干预措施
Hypofractionated dose escalated VMAT
Experimental
Hypofractionated dose escalated VMAT radiotherapy
干预措施: Hypofractionated dose escalated VMAT (Radiation)
Conventional concurrent chemoradiation
No Intervention
Conventional concurrent chemoradiation
结局指标
主要结局
Local control in the two arms
时间窗: 33 months
Local control by RECIST criteria
次要结局
- The progression free survival in the two arms(33 months)
- The incidence of toxicity of radiotherapy by CTCAE protocol in the two arms(33 months)
研究者
Ehab Saad
Principal investigator
Cairo University
相似试验
已完成
3 期
Hypofractionated vs. Conventionally Fractionated Concurrent CRT for LD-SCLCCarcinoma, Small CellLung NeoplasmsNCT02688036Cancer Institute and Hospital, Chinese Academy of Medical Sciences860
Unknown
3 期
IG-VMAT for Localized Prostate CancerProstate CancerNCT02934685Beijing Hospital60
尚未招募
2 期
Neoadjuvant Moderately Hypofractionated Radiotherapy Combined with Chemotherapy and Immunotherapy for High-risk LARCRectal CancerNCT06599827Shanghai Zhongshan Hospital54
Unknown
2 期
Hypofractionated Chemoradiotherapy and Thymosin α1 in Unresectable or Recurrent Thymic Epithelial TumorThymoma and Thymic CarcinomaNCT03663764Sun Yat-sen University57
招募中
不适用
Hypofractionated Vs Conventional Fractionated Radiotherapy After Breast Conserving SurgeryBreast CancerNCT04025164Fudan University4,052