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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Xia He, Jiangsu Cancer Institute & Hospital
ClinicalTrials.gov Identifier:
NCT01712919
First received: October 18, 2012
Last updated: March 21, 2014
Last verified: March 2014
  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:


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 ]

Enrollment: 61
Study Start Date: May 2010
Study Completion Date: March 2014
Primary Completion Date: March 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: March 21, 2014
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
Head and Neck Neoplasms
Nasopharyngeal Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Pharyngeal Neoplasms
Stomatognathic Diseases
Cetuximab
Nedaplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014