NCT01712919

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2010

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 24, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

March 24, 2014

Status Verified

March 1, 2014

Enrollment Period

3.8 years

First QC Date

October 18, 2012

Last Update Submit

March 21, 2014

Conditions

Nasopharyngeal Carcinoma

Keywords

Locoregionally advanced nasopharyngeal carcinomacetuximabchemoradiation

Outcome Measures

Primary Outcomes (2)

  • Number of Participants with Adverse Events as a Measure of Safety

    6 months

  • Number of Participants with Adverse Events as a Measure of Safety and tolerability

    6 months

Secondary Outcomes (1)

  • Progress free survival

    24 months

Other Outcomes (1)

  • local-relapse free survival

    24 months

Study Arms (1)

cetuximab

EXPERIMENTAL

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 radiotherapyDrug: Concurrent chemotherapy with paclitaxel and nedaplatinBiological: Cetuximab

Interventions

Intensity-modulated radiotherapyRADIATION

Patients will be given intensity-modulated radiotherapy(IMRT)

cetuximab
Concurrent chemotherapy with paclitaxel and nedaplatinDRUG

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

cetuximab
CetuximabBIOLOGICAL

Patients will be given cetuximab weekly during radiation therapy

cetuximab

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically confirmed untreated NPC patients
  • locoregionally advanced (T3-4 or N2-3 M0)
  • years
  • with MRI examinations
  • ECOG ≤ 2
  • With written consent

You may not qualify if:

  • Without a second cancer
  • Pregnancy
  • With other severe diseases (blood,liver ,kidney or heart diseases)
  • Could not be staged properly
  • Without written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Radiotherapy, Intensity-ModulatedPaclitaxelnedaplatinCetuximab

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeuticsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Xia He, M.D. Ph.D.

    Jiangsu Cancer Institute & Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the department of radiation oncology

Study Record Dates

First Submitted

October 18, 2012

First Posted

October 24, 2012

Study Start

May 1, 2010

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 24, 2014

Record last verified: 2014-03

Locations

CN(1)