Chemoradiation Plus Weekly c225 Against Locoregionally Advanced Nasopharyngeal Carcinoma (NPC)

IMRT With Concurrent Chemotherapy and Cetuximab Against Locoregionally Advanced NPC: a Phase 1 Study

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01712919

Enrollment

Registered

2012-10-24

Start date

2010-05-31

Completion date

2014-03-31

Last updated

2014-03-24

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

Conditions

Nasopharyngeal Carcinoma

Keywords

Locoregionally advanced nasopharyngeal carcinoma, cetuximab, chemoradiation

Brief summary

The investigators will add weekly cetuximab (c225) to the standard care of chemoradiation against locoregionally advanced Nasopharyngeal Carcinoma (NPC), and evaluate the toxicity and efficacy of this new regimen.

Interventions

RADIATIONIntensity-modulated radiotherapy

Patients will be given intensity-modulated radiotherapy(IMRT)

DRUGConcurrent chemotherapy with paclitaxel and nedaplatin

Patients will be given 2 cycles of concurrent chemotherapy with paclitaxel and nedaplatin

BIOLOGICALCetuximab

Patients will be given cetuximab weekly during radiation therapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Pathologically confirmed untreated NPC patients * locoregionally advanced (T3-4 or N2-3 M0) * 18-65 years * with MRI examinations * ECOG ≤ 2 * With written consent

Exclusion criteria

* Without a second cancer * Pregnancy * With other severe diseases (blood,liver ,kidney or heart diseases) * Could not be staged properly * Without written consent

Design outcomes

Primary

Measure	Time frame
Number of Participants with Adverse Events as a Measure of Safety	6 months
Number of Participants with Adverse Events as a Measure of Safety and tolerability	6 months

Secondary

Measure	Time frame
Progress free survival	24 months

Other

Measure	Time frame
local-relapse free survival	24 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026