Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy (ENCORE)
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Cetuximab Combined With Intensity Modulated Radiotherapy (IMRT) and Concurrent Chemotherapy of Cisplatin in Nasopharyngeal Carcinoma |
- 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.
- 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 ]
| Enrollment: | 100 |
| Study Start Date: | July 2008 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cetuximab
400mg/m^2 intravenous infusion one week before radiotherapy, then 250mg/m^2 intravenous infusion weekly during radiotherapy
|
Drug: C225 (cetuximab)
one week before and then weekly during radiotherapy
Other Name: Erbitux
|
Eligibility| Ages Eligible for Study: | 18 Years to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| China, Guangdong | |
| Cancer Center, Sun Yat-sen University | |
| Guangzhou, Guangdong, China, 510080 | |
| 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
Additional Information:
Publications:
| Responsible Party: | Departments of Radiation Oncology, Cancer Center, Sun Yat-sen University |
| ClinicalTrials.gov Identifier: | NCT00700440 History of Changes |
| Other Study ID Numbers: | EMR62202-770, PPRA-RTOG 0001 |
| Study First Received: | June 17, 2008 |
| Results First Received: | January 11, 2010 |
| Last Updated: | March 9, 2010 |
| Health Authority: | China: Ethics Committee China: Ministry of Health China: Food and Drug Administration |
Keywords provided by Sun Yat-sen University:
|
Radiotherapy chemotherapy Drug Targeting |
loco-regionally advanced nasopharyngeal carcinoma Safety. efficacy |
Additional relevant MeSH terms:
|
Carcinoma Nasopharyngeal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site |
Nasopharyngeal Diseases Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases Cetuximab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013