Brief Title
Chemoradiation Plus Weekly c225 Against Locoregionally Advanced Nasopharyngeal Carcinoma (NPC)
Official Title
IMRT With Concurrent Chemotherapy and Cetuximab Against Locoregionally Advanced NPC: a Phase 1 Study
Brief Summary
The investigators will add weekly cetuximab (c225) to the standard care of chemoradiation against locoregionally advanced Nasopharyngeal Carcinoma (NPC), and evaluate the toxicity and efficacy of this new regimen.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Number of Participants with Adverse Events as a Measure of Safety
Secondary Outcome
Progress free survival
Condition
Nasopharyngeal Carcinoma
Intervention
Intensity-modulated radiotherapy
Study Arms / Comparison Groups
cetuximab
Description: Patients will be given intensity-modulated radiotherapy,2 cycles of concurrent chemotherapy with paclitaxel and nedaplatin,and weekly cetuximab during radiation therapy.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Radiation
Estimated Enrollment
61
Start Date
May 2010
Completion Date
March 2014
Primary Completion Date
March 2014
Eligibility Criteria
Inclusion Criteria: - Pathologically confirmed untreated NPC patients - locoregionally advanced (T3-4 or N2-3 M0) - 18-65 years - with MRI examinations - ECOG ≤ 2 - With written consent Exclusion Criteria: - Without a second cancer - Pregnancy - With other severe diseases (blood,liver ,kidney or heart diseases) - Could not be staged properly - Without written consent
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Xia He, M.D. Ph.D., ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT01712919
Organization ID
LA-chemoR-c225
Secondary IDs
JSCC-SACT-01
Responsible Party
Principal Investigator
Study Sponsor
Jiangsu Cancer Institute & Hospital
Study Sponsor
Xia He, M.D. Ph.D., Principal Investigator, Jiangsu Cancer Institute & Hospital
Verification Date
March 2014