Spots Global Cancer Trial Database for Safety and Efficacy Study of Nimotuzumab Plus Neoadjuvant and Concurrent Chemoradiotherapy to Treat Oropharynx and Hypopharynx Cancer
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Trial Identification
Brief Title: Safety and Efficacy Study of Nimotuzumab Plus Neoadjuvant and Concurrent Chemoradiotherapy to Treat Oropharynx and Hypopharynx Cancer
Official Title: Neoadjuvant and Concurrent Chemoradiotherapy Plus Nimotuzumab in Treating Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Oropharynx and Hypopharynx
Study ID: NCT01516996
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Gansu Province Medical Science Institute, Lanzhou, Gansu, China
Guangxi Tumor Hospital, Nanning, Guangxi, China
GuiZhou Cancer Hospital, Guiyang, Guizhou, China
Neimenggu Tumor Hospital, Baotou, Neimenggu, China
The Tumor Affiliated Hospital of Ningxia Medical University General Hospita, Yinchuan, Ningxia, China
Qinghai Five Hospital, Xining, Qinghai, China
Xijing Hospital, Xi-an, Shanxi, China
ShanXi Cancer Hospital, Xian, Shanxi, China
The Second People's Hospital of Sichuan, Chengdu, Sichuan, China
West China Hospital, Sichuan University, Chengdu, Sichuan, China
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, Chongqing, Sichuan, China
Xinjiang tumor hospital, The Third Affiliated Hospital of Xinjiang Medical University, Wulumuqi, Xinjiang, China
Yunnan Tumor Hospital, The Third Affiliated Hospital of KUNMING Medical University, Kunming, Yunnan, China
Contact Details
Name: Yi J Lang, M.D.
Affiliation: Radiotherapy department
Role: PRINCIPAL_INVESTIGATOR
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