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Induction Chemotherapy Followed by Concurrent Radiation With Cetuximab or Cisplatin in Locally Advanced Nasopharyngeal Cancer

NCT01614938 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2012-06-08

No results posted yet for this study

Summary

The purpose of this study is to compare the efficacy and toxicity of docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent radiotherapy with cetuximab or weekly cisplatin in locally advanced nasopharyngeal carcinoma.

Conditions

  • Nasopharyngeal Carcinoma

Interventions

DRUG

Cetuximab

400 mg/m2 initial dose before radiation, then 250 mg/m2 weekly during radiation

DRUG

Cisplatin

2 cycles of induction chemotherapy every 3 weeks with cisplatin 80 mg/m2 D1-3

DRUG

Docetaxel

2 cycles of induction chemotherapy every 3 weeks with docetaxel 75 mg/m2 D1

RADIATION

Intensity-modulated radiotherapy

a total dose of 66-70.4Gy in 30-32 fractions over 6-6.5 weeks planned to be delivered to the PTV of gross tumor

DRUG

Cisplatin

2 cycles of induction chemotherapy every 3 weeks with cisplatin 80 mg/m2 D1-3, then 6 cycles of concomitant chemotherapy every week with cisplatin 30 mg/m2 D1

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Guopei Zhu, M.D. · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • China

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 NCT01614938 on ClinicalTrials.gov