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


Phase 2
18 Years
69 Years
Open (Enrolling)
Both
Nasopharyngeal Carcinoma

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Trial Information

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


Inclusion Criteria:



- Histologic diagnosis of nasopharyngeal carcinoma

- Range from 18~69 years old

- T3-4,N0-2,M0 (AJCC 2009)

- KPS ≥ 80

- Nonmetastatic diseases

- WBC count ≥ 4×109/L,Hemoglobin ≥ 100g/L, platelet count ≥ 100×109/L

- ALT or AST < 1.5×ULN、bilirubin < 1.5×ULN

- 0Serum creatinine < 1.5×ULN

Exclusion Criteria:

- Distance metastases

- Previously treated (surgery,chemotherapy, radiation therapy,EGFR targeted
therapy or immunotherapy)

- Second malignancy within 5 years

- Precious therapy with an investigational agent

- Uncontrolled seizure disorder or other serious neurologic disease

- ≥ Grade Ш allergic reaction to any drug including in this study

- Clinically significant cardiac or respiratory disease

- Creatinine clearance < 30ml/min

- Drug or alcohol addition

- Do not have full capacity for civil acts

- Severe complication, active infection

- Concurrent immunotherapy or hormone therapy for other diseases

- Pregnancy or lactation

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

3 Month Complete Response Rate + Partial Response Rate

Outcome Description:

According to RECIST (Response Evaluation Criteria in Solid Tumors) criteria, Complete response was defined as disappearance of all target lesions, Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions.

Outcome Time Frame:

3 Months

Safety Issue:

No

Principal Investigator

Chong Zhao

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sun Yat-sen University

Authority:

China: Ethics Committee

Study ID:

REPLACE

NCT ID:

NCT01271439

Start Date:

September 2010

Completion Date:

October 2014

Related Keywords:

  • Nasopharyngeal Carcinoma
  • Carcinoma
  • Nasopharyngeal Neoplasms

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