Phase 2
N=100
Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy
Nasopharyngeal Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00700440 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Mar 2010
Primary outcome: Primary: 3 Month Loco-regional Control After Cetuximab With Concurrent Chemoradiotherapy — 100 participants with loco-regional control
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- C225 (cetuximab) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sun Yat-sen University
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 3 Month Loco-regional Control After Cetuximab With Concurrent Chemoradiotherapy |
100 | — |
| SECONDARY 1,3,5 Year Loco-regional Control Rate, 1 Year Progression-free Survival and Metastasis-free Survival, 3 and 5 Year Overall Survival |
— | — |
Summary
This is an open, multicenter phase Ⅱ clinical trial on cetuximab (C225) combined with IMRT + concurrent chemotherapy of cisplatin in locoregionally advanced nasopharyngeal carcinoma.
Eligibility 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 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 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
Data sourced from ClinicalTrials.gov (NCT00700440). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.