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A Phase II Study of Neoadjuvant Chemotherapy + IMRT Combined with Cetuximab in Advanced T Stage of Nasopharyngeal Carcinoma

A Phase II Study of Neoadjuvant Chemotherapy + IMRT Combined with Cetuximab in Advanced T Stage of Nasopharyngeal Carcinoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-TNC-11001145
Enrollment
Unknown
Registered
2011-01-01
Start date
2010-09-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

1:Neoadjuvant Chemotherapy + IMRT Combined with Cetu

Sponsors

Cancer Center of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 69 Years

Inclusion criteria

Inclusion criteria: 1. Histologic diagnosis of nasopharyngeal carcinoma; 2. Aged between 18 and 69 years; 3. T3-4,N0-2,M0 (AJCC 2009); 4. KPS>=80; 5. No distant metastasis; 6. WBC count>=4*10^9/L, Hemoglobin>=100g/L, platelet count>=100*10^9/L; 7. ALAT or AST<1.5*ULN, bilirubin<1.5*ULN; 8. Serum creatinine<1.5*ULN.

Exclusion criteria

Exclusion criteria: 1. Distant metastases; 2. Previously treated (surgery, chemotherapy, radiotherapy, EGFR targeted therapy or immunotherapy); 3. Second malignancy within 5 years; 4. Precious therapy with an investigational agent; 5. Uncontrolled seizure disorder or other serious neurologic disease; 6. Allergic reaction (>=Grade III) to any drug including in this study; 7. Clinically significant cardiac or respiratory disease; 8. Creatinine clearance <30ml/min; 9. Drug or alcohol addiction; 10. Do not have full capacity for civil acts; 11. With severe complications or active infection; 12. Concurrent immunotherapy or hormone therapy for other diseases; 13. Pregnancy or lactation.

Design outcomes

Primary

MeasureTime frame
Acute Toxicity;Efficacy in three month;

Secondary

MeasureTime frame
quality of life;the relationship between patient outcome and gene;one and three years locoregional failure-free rate;

Countries

China

Contacts

Public ContactChong ZHAO, Yunfeng ZHOU
zhaochong@sysucc.org.cn+86 13902206160

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026