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

Phase 1

Completed

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Radiation: Intensity-modulated radiotherapy; Drug: Concurrent chemotherapy with paclitaxel and nedaplatin; Biological: Cetuximab

• Registration Number: NCT01712919
• Lead Sponsor: Jiangsu Cancer Institute & Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2012-10-18
• Study First Submitted QC: 2012-10-23
• Study First Posted: 2012-10-24
• Status Verified: 2014-03
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Last Update Submitted: 2014-03-21
• Last Update Posted: 2014-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Progress free survival	24 months

Trial Locations

Locations (1)

Jiangsu Cancer Hospital; 🇨🇳 Nanjing, Jiangsu, China