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

This study is currently recruiting participants.
Verified November 2012 by Jiangsu Cancer Institute & Hospital
Sponsor:
Information provided by (Responsible Party):
Dr. Xia He, Jiangsu Cancer Institute & Hospital
ClinicalTrials.gov Identifier:
NCT01712919
First received: October 18, 2012
Last updated: November 14, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Nasopharyngeal Carcinoma
 Radiation: Intensity-modulated radiotherapy
Drug: Concurrent chemotherapy with paclitaxel and nedaplatin
Biological: Cetuximab
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: IMRT With Concurrent Chemotherapy and Cetuximab Against Locoregionally Advanced NPC: a Phase 1 Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Jiangsu Cancer Institute & Hospital:

Primary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Number of Participants with Adverse Events as a Measure of Safety and tolerability [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progress free survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • local-relapse free survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712919

Contacts
Contact: Jianhua Xu, M.D. 15805161106 xu016@sohu.com

Locations
China, Jiangsu
Jiangsu Cancer Hospital Recruiting
Nanjing, Jiangsu, China, 210009
Contact: Jianhua Xu, M.D.     15805161106     xu016@sohu.com    
Principal Investigator: Xia He, M.D. Ph.D            
Sponsors and Collaborators
Jiangsu Cancer Institute & Hospital
Investigators
Principal Investigator: Xia He, M.D. Ph.D. Jiangsu Cancer Institute & Hospital
  More Information

No publications provided

Responsible Party: Dr. Xia He, Director of the department of radiation oncology, Jiangsu Cancer Institute & Hospital
ClinicalTrials.gov Identifier: NCT01712919     History of Changes
Other Study ID Numbers: LA-chemoR-c225, JSCC-SACT-01
Study First Received: October 18, 2012
Last Updated: November 14, 2012
Health Authority: China: Ethics Committee

Keywords provided by Jiangsu Cancer Institute & Hospital:
Locoregionally advanced nasopharyngeal carcinoma
cetuximab
chemoradiation

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
 Otorhinolaryngologic Diseases
Nedaplatin
Cetuximab
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on June 18, 2013