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Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy (ENCORE)
This study is currently recruiting participants.
Verified by Sun Yat-sen University, June 2008
Sponsors and Collaborators: Sun Yat-sen University
Chinese Academy of Medical Sciences
Fudan University
Cancer Center of Sichuan province
Cancer Center of Fujian province
Cancer Center of Guizhou province
The First Affiliated Hospital of Guangxi Medical University
Wuhan University
Information provided by: Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00700440
  Purpose

This is an open, multicenter phase Ⅱ clinical trial on cetuximab (C225) combined with IMRT + concurrent chemotherapy of cisplatin in locoregionally advanced nasopharyngeal carcinoma.


Condition Intervention Phase
Nasopharyngeal Carcinoma
Drug: C225 (cetuximab)
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Cisplatin Cetuximab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase II Study of Cetuximab Combined With IMRT and Concurrent Chemotherapy of Cisplatin in Nasopharyngeal Carcinoma

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Safety and 3 month loco-regional control rate after cetuximab with concurrent chemoradiotherapy [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 1,3,5 year loco-regional control rate, 1 year progression-free survival and metastasis-free survival, 3 and 5 year overall survival [ Time Frame: 5 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2008
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: C225 (cetuximab)
    400mg/m2 1 week before radiotherapy, then 250mg/m2 weekly during radiotherapy
  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent form signed prior to study entry
  • Age between 18-69 years old
  • Pathology approved to be nasopharyngeal carcinoma (types WHO Ⅱ-Ⅲ)
  • Stage Ⅲ, Ⅳa, Ⅳb (M0) according to UICC 2002 6th edition criteria
  • Primary tumor measurable
  • KPS score ≥80
  • Expected life span ≥6 months
  • Adequate bone marrow function: WBC≥4×109/L,Hb≥100g/L,PLT≥100×109/L
  • Adequate liver function: ALAT/ASAT<1.5 ×ULN, bilirubin <1.5×ULN
  • Adequate renal function: Creatinine Clearance < 1.5×ULN

Exclusion Criteria:

  • Evidence of distant metastatic disease
  • Surgical procedure of the primary tumor or lymph nodes (except diagnostic biopsy)
  • Previous radiotherapy for the primary tumor or lymph nodes
  • Previous exposure to epidermal growth factor-targeted therapy
  • Prior chemotherapy or immunotherapy for the primary tumor
  • Other previous malignancy within 5 years, except non-melanoma skin cancer or pre-invasive carcinoma of the cervix
  • Any investigational agent prior to the 1st study medication
  • Participation in another clinical study within the 30 days prior to Inclusion in this study.
  • Peripheral neuropathy > grade 1
  • Known grade 3 or 4 allergic reaction to any of the study treatment
  • History of severe pulmonary or cardiac disease
  • Creatinine Clearance < 30ml/min
  • Know drug abuse / alcohol abuse
  • Legal incapacity or limited legal capacity
  • Active systemic infection
  • Medical or psychiatric illness, which in the investigators' opinions, would not permit the subject to complete or fully and completely understand the risks and potential complications of the study
  • Concurrent chronic systemic immune therapy or hormone therapy not indicated in the study protocol
  • Pregnancy (confirmed by serum or urine β-HCG) or lactation period
  • Severe intercurrent illness, e.g. uncontrolled hypertension, cardiac failure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00700440

Contacts
Contact: Tai-xiang Lu, M.D. 86-20-873-4332 lutx@mail.sysu.edu.cn
Contact: Chun-yan Chen, M.D. 86-20-873-4332 sumsccy@163.com

Locations
China, Guangdong
Cancer Center, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Tai-xiang Lu, M.D.     86-20-8734-3372     lutx@mail.sysu.edu.cn    
Contact: Chun-yan Chen, M.D.     86-20-8734-3372     sumsccy@163.com    
Principal Investigator: Tai-xiang Lu, M.D.            
Sub-Investigator: Chong Zhao, M.D.            
Sponsors and Collaborators
Sun Yat-sen University
Chinese Academy of Medical Sciences
Fudan University
Cancer Center of Sichuan province
Cancer Center of Fujian province
Cancer Center of Guizhou province
The First Affiliated Hospital of Guangxi Medical University
Wuhan University
Investigators
Principal Investigator: Tai-xiang Lu, M.D. Departments of Radiation Oncology, Cancer Center, Sun Yat-sen University
Principal Investigator: Tong-yu Lin, M.D., PhD Departments of Chemotherapy, Cancer Center, Sun Yat-sen University
  More Information

Home Page of Cancer Center, Sun Yat-sen University  This link exits the ClinicalTrials.gov site
Home Page of Chinese Anti-Cancer Association  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: Cancer Center, Sun Yat-sen University ( Departments of Radiation Oncology )
Study ID Numbers: EMR62202-770, PPRA-RTOG 0001
Study First Received: June 17, 2008
Last Updated: July 21, 2008
ClinicalTrials.gov Identifier: NCT00700440  
Health Authority: China: Ethics Committee;   China: Ministry of Health;   China: State Food and Drug Administration

Keywords provided by Sun Yat-sen University:
Radiotherapy
chemotherapy
Drug Targeting
loco-regionally advanced nasopharyngeal carcinoma
Safety.
efficacy

Study placed in the following topic categories:
Nasopharyngeal carcinoma
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Cisplatin
Head and Neck Neoplasms
Cetuximab
Pharyngeal Neoplasms
Stomatognathic Diseases
Pharyngeal Diseases
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses
Nasopharyngeal Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009