Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy (ENCORE)

This study has been completed.
Sponsor:
Collaborators:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sichuan Cancer Hospital and Research Institute
Fujian Cancer Hospital
Fudan University
Cancer Hospital of Guizhou Province
Guangxi Medical University
Central South University
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00700440
First received: June 17, 2008
Last updated: March 9, 2010
Last verified: February 2009

June 17, 2008
March 9, 2010
July 2008
April 2009   (final data collection date for primary outcome measure)
3 Month Loco-regional Control After Cetuximab With Concurrent Chemoradiotherapy [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

The response status (Complete Response + Partial Response) was evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Complete response was defined as disappearance of all target lesions, and Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions, taking as reference the baseline study.

Adverse events of this combined modality treatment were graded according to CTCAE (Common Terminology Criteria for Adverse Events) v3.0 criteria.

Safety and 3 month loco-regional control rate after cetuximab with concurrent chemoraiotherapy [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00700440 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy
Phase II Study of Cetuximab Combined With Intensity Modulated Radiotherapy (IMRT) and Concurrent Chemotherapy of Cisplatin in Nasopharyngeal Carcinoma

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

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Nasopharyngeal Carcinoma
Drug: C225 (cetuximab)
one week before and then weekly during radiotherapy
Other Name: Erbitux
Experimental: Cetuximab
400mg/m^2 intravenous infusion one week before radiotherapy, then 250mg/m^2 intravenous infusion weekly during radiotherapy
Intervention: Drug: C225 (cetuximab)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
April 2009
April 2009   (final data collection date for primary outcome measure)

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 according to UICC (International Union Against Cancer) 2002 6th edition criteria
  • Primary tumor measurable
  • KPS score ≥80
  • Expected life span ≥6 months
  • Adequate bone marrow function: White Blood Cell≥4×109/L,Hemoglobin≥100g/L,Platelet≥100×109/L
  • Adequate liver function: ALAT/ASAT<1.5 × upper limit of normal (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
Both
18 Years to 69 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00700440
EMR62202-770, PPRA-RTOG 0001
Yes
Departments of Radiation Oncology, Cancer Center, Sun Yat-sen University
Sun Yat-sen University
  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Sichuan Cancer Hospital and Research Institute
  • Fujian Cancer Hospital
  • Fudan University
  • Cancer Hospital of Guizhou Province
  • Guangxi Medical University
  • Central South University
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
Sun Yat-sen University
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP