NCT01271439

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

August 13, 2013

Status Verified

November 1, 2011

Enrollment Period

1.8 years

First QC Date

January 5, 2011

Last Update Submit

August 10, 2013

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 3 Month Complete Response Rate + Partial Response Rate

    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.

    3 Months

Secondary Outcomes (10)

  • One-year locoregional control rate

    1 year

  • Three-year locoregional control rate

    3 years

  • One-year disease free survival rate

    1 year

  • Three-year disease free survival rate

    3 years

  • One-year overall survival rate

    1 year

  • +5 more secondary outcomes

Study Arms (1)

cetuximab

EXPERIMENTAL
Drug: Cetuximab

Interventions

CetuximabDRUG

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

Also known as: C225
cetuximab

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Serum creatinine \< 1.5×ULN

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Links

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Chong Zhao

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

  • Yunfeng Zhou

    Zhongnan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 5, 2011

First Posted

January 6, 2011

Study Start

September 1, 2010

Primary Completion

June 1, 2012

Study Completion

December 1, 2012

Last Updated

August 13, 2013

Record last verified: 2011-11

Locations

CN(1)