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Completed

NCT Number: NCT01271439

Study of Chemoradiotherapy Combined With Cetuximab in Nasopharyngeal Carcinoma

This is an open, multicenter phase Ⅱ clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of cetuximab (C225) combined with IMRT + neoadjuvant chemotherapy in advanced T stage of nasopharyngeal carcinoma. Besides, to figure out the relationship between patient outcome and EGFR gene copy number, expression and mutation.

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Key information

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cetuximab

Drug

400mg/m2 intravenous infusion the week before radiotherapy, 250mg/m2 intravenous infusion weekly for 6 weeks during radiotherapy

Other names: C225

Primary outcomes

  1. 3 Month Complete Response Rate + Partial Response Rate

    Time frame: 3 Months

    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.

Secondary outcomes

  1. One-year locoregional control rate

    Time frame: 1 year

    locoregional control rate: from the time when finish treatment to persistence or recurrence in the nasopharyngeal and/or cervical region.

  2. Three-year locoregional control rate

    Time frame: 3 years

    locoregional control rate: from the time when finish treatment to persistence or recurrence in the nasopharyngeal and/or cervical region.

  3. One-year disease free survival rate

    Time frame: 1 year

    disease free survival rate: from the time when finish treatment to first failure at any site.

  4. Three-year disease free survival rate

    Time frame: 3 years

    disease free survival rate: from the time when finish treatment to first failure at any site.

  5. One-year overall survival rate

    Time frame: 1 year

    overall survival rate: from the time when finish treatment to death of any cause.

  6. Three-year overall survival rate

    Time frame: 3 years

    overall survival rate: from the time when finish treatment to death of any cause.

  7. The relationship between 3 years overall survival rate and expression of EGFR

    Time frame: 3 years

    all patients must have sufficient pretreatment tumor biopsy specimens.

  8. Use EORTC QLQ-C30(version 3.0) and EORTC QLQ-H&N35(Version 1.0) to access the quality of life

    Time frame: 3 years

    collect date before treatment, the week using neoadjuvant chemotherapy, every week during radiotherapy, 6 months and every year after all treatment finished.

  9. The relationship between 3 years overall survival rate and amplification of EGFR

    Time frame: 3 years

    all patients must have sufficient pretreatment tumor biopsy specimens.

  10. The relationship between 3 years overall survival rate and mutation of EGFR

    Time frame: 3 years

    all patients must have sufficient pretreatment tumor biopsy specimens.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Affiliated Cancer Hospital of Shantou University Medical College
  • First Affiliated Hospital of Guangxi Medical University
  • First People's Hospital of Foshan
  • Hubei Cancer Hospital
  • Hunan Cancer Hospital
  • Jiangxi Provincial Cancer Hospital
  • Shenzhen People's Hospital
  • Tongji University
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Wenzhou Medical University
  • Wuhan University
  • Xijing Hospital
  • Zhejiang Cancer Hospital

Registry information

Official study title

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

Acronym: REPLACE

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 6, 2011
Registry last updated
Aug 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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