De-escalation of Chemoradiotherapy Density in HPV-related Oropharyngeal Carcinoma in Chinese Populations
试验速览
- 阶段
- 不适用
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
Human papillomavirus (HPV)-related oropharyngeal carcinoma are exquisitely radiosensitive. Several studies attempted to reduce the toxicities of treatments through reduced-dose radiation and showed promising results, but all data were collected from non-Chinese areas. Like nasopharyngeal carcinoma, oropharyngeal carcinoma may have different biological behavior and relationship with HPV infection. So the investigators studied whether toxicities reducing treatment with reduced radiation dose and omitted concurrent chemotherapy after good response to induction chemotherapy would maintain survival outcomes while improving tolerability for patients with HPV-positive oropharyngeal carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Histological diagnosis of squamous cell carcinoma of oropharynx with IHC p16 positive or PCR HPV16 positive
- •T1-2/N1-3M0（except T1N1M0 and single LN<3cm）or T3-4N0-3M0 according to UICC/AJCC 8th staging system
- •No prior anti-tumor treatment
- •Karnofsky Performance Score (KPS)≥70
- •Adequate blood supply
- •Informed consent obtained
排除标准
- •cannot take contrast-MRI imaging
- •Combined with other malignant tumor (except basal cell carcinoma of skin)
研究组 & 干预措施
conventional treatment arm
Two cycles docetaxel+cisplatin (TP) induction chemotherapy followed by concurrent cisplatin chemoradiotherapy with standard radiation dose (70Gy/35Fx) when responses to induction chemotherapy are less than 50% Partial Response(PR)
干预措施: conventional treatment (Other)
Toxicities reduced treatment arm
Two cycles docetaxel+cisplatin (TP) induction chemotherapy followed by reducing radiation dose(60Gy/30Fx) and omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR)
干预措施: Toxicities reduced treatment (Other)
结局指标
主要结局
PFS
时间窗: 2 year
Progression Free Survival
次要结局
- OS(2 year)
研究者
Chaosu Hu
Principal Investigator
Fudan University