Esophageal cancer is the sixth leading cause of cancer death in worldwide. Over the past 2 decades, well-designed clinical trials have documented the clinical benefits of combination of chemotherapy and radiation for localized esophageal cancer, either as primary therapy or in neoadjuvant setting. Paclitaxel, a radiation sensitizer, has important single-agent activity in esophageal cancer. Paclitaxel-based chemoradiation has been the framework for the recent Radiation Therapy Oncology Group (RTOG) trials of nonoperative management of esophageal cancer. Accumulating clinical evidence suggests that Epidermal Growth Factor Receptor (EGFR) represents a viable target in the treatment of esophageal cancer. EGFR expression is associated with poor prognosis. Nimotuzumab binds specifically to EGFR on both normal and tumor cells and competitively inhibits the binding of Epidermal Growth Factor (EGF) and other ligands, such as Transforming Growth Factor-α (TGF-α). Preclinical models have suggested synergy between nimotuzumab, paclitaxel, cisplatin and radiation. For our phase II study in locally advanced esophageal squamous cell carcinoma (ESCC), the combination of cetuximab and chemoradiotherapy has demonstrated both response and survival benefits. Myara et al reported that nimotuzumab plus concurrent chemoradiation therapy (CCRT) was safe and provided statistically significant objective response (47.8%) and disease control rate (60.9%) in nonresectable ESCC. With all these, the investigators plan to study phase III trial.
The primary endpoint of this study is overall survival, and the primary hypothesis is the experimental arm will improve median survival time (MST) from 18.2 month to 28.5 month. Assuming bilateral ɑ = 0.05, statistical power of 80%.Each group requires a minimum of 59 cases. Consider the 20% loss factor.The total sample size is 200 cases.It is 100 cases in each group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
400mg/w,d1, week 1-7
Three dimensional conformal RT(3DCRT)/IntensityModulatedRadiationTherapy(IMRT):1.8 Gy/f/day, T59.4 Gy/33f,week 1-7
45 mg/m2, d1, week 1-7
20 mg/m2, d1, week 1-7
400mg/w,d1, week 1-7
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGBeijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGCancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
NOT_YET_RECRUITINGThe Guangxi Zhuang Autonomous Region Cancer Hospita
Nanning, Guangxi, China
NOT_YET_RECRUITINGAffiliated Hospital of Zunyi Medical College
Zunyi, Guizhou, China
NOT_YET_RECRUITINGFourth Hospital of Hebei Medical University Tumor
Shijiazhuang, Hebei, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGJiangsu Cancer Hospital
Nanjing, Jiangsu, China
RECRUITINGAffiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
RECRUITINGThe First Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITING...and 4 more locations
Over Survival
Time frame: up to 5 years
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