Clinical trial · Interventional
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
NCT00700440CI-TRIAL-00003294ENCOREcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open, multicenter phase Ⅱ clinical trial on cetuximab (C225) combined with IMRT + concurrent chemotherapy of cisplatin in locoregionally advanced nasopharyngeal carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| C225 (cetuximab) | Drug | Cetuximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cetuximab
- description
- 400mg/m\^2 intravenous infusion one week before radiotherapy, then 250mg/m\^2 intravenous infusion weekly during radiotherapy
- interventionNames
- Drug: C225 (cetuximab)
Primary outcomes (1)
- measure
- 3 Month Loco-regional Control After Cetuximab With Concurrent Chemoradiotherapy
- timeFrame
- 3 months
- description
- 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.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 69 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDSung 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. PMID 15796181
- BACKGROUNDBonner 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. PMID 16467544
- BACKGROUNDKiss 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. PMID 1835597
- BACKGROUNDBurtness 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. PMID 16314626
- BACKGROUNDCurran 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. PMID 17538164