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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01712919
Recruitment Status : Completed
First Posted : October 24, 2012
Last Update Posted : March 24, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: IMRT With Concurrent Chemotherapy and Cetuximab Against Locoregionally Advanced NPC: a Phase 1 Study
Study Start Date : May 2010
Primary Completion Date : March 2014
Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  1. Progress free survival [ Time Frame: 24 months ]

Other Outcome Measures:
  1. local-relapse free survival [ Time Frame: 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01712919


Locations
China, Jiangsu
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China, 210009
Sponsors and Collaborators
Jiangsu Cancer Institute & Hospital
Investigators
Principal Investigator: Xia He, M.D. Ph.D. Jiangsu Cancer Institute & Hospital
More Information

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 ( Other Identifier: Department of Radiation Oncology,Jiangsu Cancer Hospital )
First Posted: October 24, 2012    Key Record Dates
Last Update Posted: March 24, 2014
Last Verified: March 2014

Keywords provided by Dr. Xia He, 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
Paclitaxel
Nedaplatin
Albumin-Bound Paclitaxel
Cetuximab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action