Neoplasms

All Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Oropharyngeal Neoplasms

Hypopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Hypopharyngeal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Nimotuzumab

Cisplatin

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

* The neoadjuvant consists of docetaxel 75mg/m2 day 1 and cisplatin 75mg/m2 days 1 to 3, repeat every 3 weeks, for 2 cycles.
* CCRT: cisplatin 75mg/m2 is administered on day 1 of week 7,10 and 13 on current with RT

docetaxel and cisplatin

IMRT is administered with chemotherapy from week 7 to week 13

* GTV（primary tumor）：68-70Gy/35\~38 F，once a day, 5 times per week
* CTV（Clinical target）：56-66Gy/30\~36f，once a day, 5 times per week
* GTV-ln（positive neck region）：66-70Gy/33\~36 F，once a day, 5 times per week
* CTV-ln（negative neck region）：50-54Gy/28\~30F, once a day, 5 times

IMRT

Nimotuzumab was administered 200 mg IV over 1 hour on day 1,once a week, for 13\~14 weeks

Peng Xu, M.D.

Yi J Lang, M.D.

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.

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.

Safety and Efficacy Study of Nimotuzumab Plus Neoadjuvant and Concurrent Chemoradiotherapy to Treat Oropharynx and Hypopharynx Cancer

Neoadjuvant and Concurrent Chemoradiotherapy Plus Nimotuzumab in Treating Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Oropharynx and Hypopharynx

Objective Response Rate: Complete response (CR)+ partial response (PR) rates base on RECIST evaluation system.

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.

To evaluate each year until 5 years later

Biotech Pharmaceutical Co., Ltd.

The Second People's Hospital of Sichuan

Professor of radiotherapy department

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety and Efficacy Study of Nimotuzumab Plus Neoadjuvant and Concurrent Chemoradiotherapy to Treat Oropharynx and Hypopharynx Cancer	NCT01516996	Oropharyngeal C... Hypopharyngeal ...	docetaxel and c... IMRT Nimotuzumab	18 Years - 70 Years	The Second People's Hospital of Sichuan
Safety and Efficacy Study of Nimotuzumab Plus Neoadjuvant and Concurrent Chemoradiotherapy to Treat Oropharynx and Hypopharynx Cancer	NCT01516996	Oropharyngeal C... Hypopharyngeal ...	docetaxel and c... IMRT Nimotuzumab	18 Years - 70 Years	The Second People's Hospital of Sichuan

Spots Global Cancer Trial Database for locoregionally advanced oropharynx