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Completed

NCT Number: NCT01712919

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

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.

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Key information

Conditions

Nasopharyngeal Carcinoma Carcinoma Head and Neck Neoplasms Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210009, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensity-Modulated Radiotherapy

Radiation

Patients will be given intensity-modulated radiotherapy(IMRT)

Concurrent chemotherapy with paclitaxel and nedaplatin

Drug

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

Cetuximab

Biological

Patients will be given cetuximab weekly during radiation therapy

Primary outcomes

  1. Number of Participants with Adverse Events as a Measure of Safety

    Time frame: 6 months

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

    Time frame: 6 months

Secondary outcomes

  1. Progress free survival

    Time frame: 24 months

Other outcomes

  1. local-relapse free survival

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Jiangsu Cancer Institute & Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Oct 24, 2012
Registry last updated
Mar 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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