Neoadjuvant and Concurrent Chemoradiotherapy Plus Nimotuzumab in Treating Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Oropharynx and Hypopharynx
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 试验地点
- 13
- 主要终点
- Objective response rate
研究概览
简要总结
The purpose of this study is to evaluate the efficiency and safety of adding nimotuzumab to neoadjuvant and concurrent chemoradiotherapy in the treatment of patients with locoregionally advanced squamous cell carcinoma of the oropharynx and hypopharynx.
详细描述
Locoregionally advanced squamous cell carcinoma of the head and neck(LA-SCCHN) poses one of the most complex management challenges. This stage of disease is still potentially curable, but requires combined-modality therapy. Recent studies have showed that induction chemotherapy（neoadjuvant）reduced the 3-year distant relapse rate. Concurrent chemoradiotherapy(CCRT), on the other hand, has demonstrated a significant and consistent benefit in local control rates, but its impact on distant failure is inconsistent. Nimotuzumab is a novel EGFR-targeting monoclonal antibody that has the potential.to be used as a single agent or as a radio- and chemotherapy sensitizer for the treatment of SCCHN. Thus, investigators conducted a randomized, multicenter phaseⅡ study to compare the efficiency and safety of adding nimotuzumab to neoadjuvant and CCRT with neoadjuvant and CCRT in the treatment of patients with locoregionally advanced squamous cell carcinoma of the oropharynx and hypopharynx.
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
- •Informed consent form
- •Histologically confirmed locally advanced (stages III and IVb), squamous cell carcinoma of the oropharynx and hypopharynx
- •The tumor mass had to be measurable
- •Karnofsky performance status ≥70
- •Life expectancy estimated than 6 months
- •Hematologic: WBC≥4×109 /L , plateletes≥100×109 /L, haemoglobin ≥100 g/L；
- •Hepatic: AST/ALT<1.5 times upper limit of normal (ULN)；serum bilirubin<1.5 times ULN;
- •Renal: Creatinine<1.5 times ULN；
排除标准
- •Known distant metastases
- •Primary tumor and nodes received surgery(except of biopsy)
- •Received other anti EGFR monoclonal antibody treatment
- •Previous chemotherapy or radiotherapy
- •Participation in other interventional clinical trials within 1 month
- •Other malignant tumor (except of non-melanoma skin Cancer or carcinoma in situ of cervix)
- •History of serious allergic or allergy
- •History of Serious lung or heart disease
- •Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant
研究组 & 干预措施
Neoadjuvant and CCRT and Nimotuzumab
干预措施: Nimotuzumab (Biological)
Neoadjuvant and CCRT
干预措施: docetaxel and cisplatin (Drug)
Neoadjuvant and CCRT
干预措施: IMRT (Radiation)
Neoadjuvant and CCRT and Nimotuzumab
干预措施: docetaxel and cisplatin (Drug)
Neoadjuvant and CCRT and Nimotuzumab
干预措施: IMRT (Radiation)
结局指标
主要结局
Objective response rate
时间窗: 3 months after all the treatment ending
Objective Response Rate: Complete response (CR)+ partial response (PR) rates base on RECIST evaluation system.
The Number of Participants with Adverse Events
时间窗: Participants will be followed during the treatment and 3 months after all the treatment ending ,an expected average of 26 weeks
Record the Number of participants with adverse events and the Grades of the AE according to CTCAE v3.0 as the two measure of safety.
次要结局
- Evaluate the Local control Rate in 1 to 5 years.(Participants will be followed every year for the duration of 5 years)
- Overall Survival(From date of randomization until the date of death from any cause,assessed up to 5 years)
- Progression-Free Survival(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)
- Tumor-Free Survival(From date of randomization until the date of first documented occurrence of primary, neck, distant relapse,assessed up to 5 years)
- Non-metastatic Rate(The time from randomization until distant relapse occur,assessed up to 5 years)
研究者
LANG Jin-yi
Professor of radiotherapy department
The Second People's Hospital of Sichuan