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Induction and Concurrent Chemoradiotherapy With Cetuximab for Patients With Locally Advanced Nasopharyngeal Carcinoma

NCT01230476 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2019-10-07

No results posted yet for this study

Summary

Standard of care for treatment of nasopharyngeal carcinoma is chemoradiation with concurrent cisplatin. Addition of a second agent, cetuximab, which targets nasopharyngeal carcinoma cells with high EGFR protein expression, may enhance the effectiveness of radiation and result in better tumour control. This study investigates the addition of 2 cycles of cisplatin/5FU chemotherapy with cetuximab, followed by cisplatin and cetuximab concurrent with radiation, for treatment of locally advanced nasopharyngeal carcinoma.

Conditions

  • Nasopharyngeal Carcinoma

Interventions

DRUG

Cetuximab

Cetuximab loading dose of 400mg/m2, then weekly dose of 250mg/m2 for 12 doses; Neoadjuvant Cisplatin 75mg/m2 D1, 5FU 1000mg/m2 D2-5, for 2 cycles; Concurrent Cisplatin 30mg/m2 given with radiation 70Gy/35fraction/7weeks.

Sponsors & Collaborators

  • Merck Serono International SA

    collaborator INDUSTRY

  • University of Malaya

    lead OTHER

Principal Investigators

  • Gwo Fuang Ho, FRCR · University of Malaya

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2013-05-31
Completion
2015-05-31

Countries

  • Malaysia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01230476 on ClinicalTrials.gov