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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2014-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Nasopharyngeal Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cetuximab

Patients will be given intensity-modulated radiotherapy,2 cycles of concurrent chemotherapy with paclitaxel and nedaplatin,and weekly cetuximab during radiation therapy.

Group Type EXPERIMENTAL

Intensity-modulated radiotherapy

Intervention Type RADIATION

Patients will be given intensity-modulated radiotherapy(IMRT)

Concurrent chemotherapy with paclitaxel and nedaplatin

Intervention Type DRUG

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

Cetuximab

Intervention Type BIOLOGICAL

Patients will be given cetuximab weekly during radiation therapy

Interventions

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Intensity-modulated radiotherapy

Patients will be given intensity-modulated radiotherapy(IMRT)

Intervention Type RADIATION

Concurrent chemotherapy with paclitaxel and nedaplatin

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

Intervention Type DRUG

Cetuximab

Patients will be given cetuximab weekly during radiation therapy

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No