- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00700440
Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy (ENCORE)
Phase II Study of Cetuximab Combined With Intensity Modulated Radiotherapy (IMRT) and Concurrent Chemotherapy of Cisplatin in Nasopharyngeal Carcinoma
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510080
- Cancer Center, Sun Yat-sen University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cetuximab
400mg/m^2 intravenous infusion one week before radiotherapy, then 250mg/m^2 intravenous infusion weekly during radiotherapy
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one week before and then weekly during radiotherapy
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
3 Month Loco-regional Control After Cetuximab With Concurrent Chemoradiotherapy
Time Frame: 3 months
|
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. |
3 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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5 year
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Collaborators and Investigators
Sponsor
Collaborators
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
Publications and helpful links
General Publications
- Bonner JA, Harari PM, Giralt J, Azarnia N, Shin DM, Cohen RB, Jones CU, Sur R, Raben D, Jassem J, Ove R, Kies MS, Baselga J, Youssoufian H, Amellal N, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med. 2006 Feb 9;354(6):567-78. doi: 10.1056/NEJMoa053422.
- Sung FL, Poon TC, Hui EP, Ma BB, Liong E, To KF, Huang DP, Chan AT. Antitumor effect and enhancement of cytotoxic drug activity by cetuximab in nasopharyngeal carcinoma cells. In Vivo. 2005 Jan-Feb;19(1):237-45.
- Kiss R, Salmon I, Pauwels O, Gras S, Danguy A, Etievant C, Pasteels JL, Martinez J. In vitro influence of gastrin, oestradiol and gonadotropin-releasing hormone on HCT-15 and LoVo human colorectal neoplastic cell proliferation. Eur J Cancer. 1991;27(10):1268-74. doi: 10.1016/0277-5379(91)90095-u.
- Burtness B, Goldwasser MA, Flood W, Mattar B, Forastiere AA; Eastern Cooperative Oncology Group. Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: an Eastern Cooperative Oncology Group study. J Clin Oncol. 2005 Dec 1;23(34):8646-54. doi: 10.1200/JCO.2005.02.4646. Erratum In: J Clin Oncol. 2006 Feb 1;24(4):724.
- Curran D, Giralt J, Harari PM, Ang KK, Cohen RB, Kies MS, Jassem J, Baselga J, Rowinsky EK, Amellal N, Comte S, Bonner JA. Quality of life in head and neck cancer patients after treatment with high-dose radiotherapy alone or in combination with cetuximab. J Clin Oncol. 2007 Jun 1;25(16):2191-7. doi: 10.1200/JCO.2006.08.8005. Erratum In: J Clin Oncol. 2007 Aug 20;25(24):3790.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Cetuximab
Other Study ID Numbers
- EMR62202-770
- PPRA-RTOG 0001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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