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

PHASE2UnknownINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

September 30, 2013

Study Completion Date

March 31, 2018

Conditions
Oropharyngeal CancerHypopharyngeal Cancer
Interventions
DRUG

docetaxel and cisplatin

"* 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"

RADIATION

IMRT

"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"

BIOLOGICAL

Nimotuzumab

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

Trial Locations (13)

400042

ACTIVE_NOT_RECRUITING

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, Chongqing

530021

ACTIVE_NOT_RECRUITING

Guangxi Tumor Hospital, Nanning

550004

ACTIVE_NOT_RECRUITING

GuiZhou Cancer Hospital, Guiyang

610041

RECRUITING

The Second People's Hospital of Sichuan, Chengdu

ACTIVE_NOT_RECRUITING

West China Hospital, Sichuan University, Chengdu

652100

ACTIVE_NOT_RECRUITING

Yunnan Tumor Hospital, The Third Affiliated Hospital of KUNMING Medical University, Kunming

710032

ACTIVE_NOT_RECRUITING

Xijing Hospital, Xi’an

710061

ACTIVE_NOT_RECRUITING

ShanXi Cancer Hospital, Xian

730050

ACTIVE_NOT_RECRUITING

Gansu Province Medical Science Institute, Lanzhou

750004

ACTIVE_NOT_RECRUITING

The Tumor Affiliated Hospital of Ningxia Medical University General Hospita, Yinchuan

830000

ACTIVE_NOT_RECRUITING

Xinjiang tumor hospital, The Third Affiliated Hospital of Xinjiang Medical University, Ürümqi

014030

ACTIVE_NOT_RECRUITING

Neimenggu Tumor Hospital, Baotou

Unknown

ACTIVE_NOT_RECRUITING

Qinghai Five Hospital, Xining

Sponsors
All Listed Sponsors
collaborator

Biotech Pharmaceutical Co., Ltd.

OTHER

lead

The Second People's Hospital of Sichuan

OTHER