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

March 21, 2014 updated by: Dr. Xia He, Jiangsu Cancer Institute & Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Jiangsu Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cetuximab
Patients will be given intensity-modulated radiotherapy,2 cycles of concurrent chemotherapy with paclitaxel and nedaplatin,and weekly cetuximab during radiation therapy.
Radiation: Intensity-modulated radiotherapy
Patients will be given intensity-modulated radiotherapy(IMRT)
Drug: Concurrent chemotherapy with paclitaxel and nedaplatin
Patients will be given 2 cycles of concurrent chemotherapy with paclitaxel and nedaplatin
Biological: Cetuximab
Patients will be given cetuximab weekly during radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Adverse Events as a Measure of Safety
Time Frame: 6 months
6 months
Number of Participants with Adverse Events as a Measure of Safety and tolerability
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Progress free survival
Time Frame: 24 months
24 months

Other Outcome Measures

Outcome Measure
Time Frame
local-relapse free survival
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Cancer Institute & Hospital

Investigators

  • Principal Investigator: Xia He, M.D. Ph.D., Jiangsu Cancer Institute & Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

October 18, 2012

First Submitted That Met QC Criteria

October 23, 2012

First Posted (Estimate)

October 24, 2012

Study Record Updates

Last Update Posted (Estimate)

March 24, 2014

Last Update Submitted That Met QC Criteria

March 21, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LA-chemoR-c225
  • JSCC-SACT-01 (Other Identifier: Department of Radiation Oncology,Jiangsu Cancer Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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