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Intensity-modulated Radiation Therapy Combined With Cisplatin or Nedaplatin Chemotherapy in Nasopharyngeal Carcinoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2010 by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01265147
First Posted: December 23, 2010
Last Update Posted: January 20, 2011
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.
Information provided by:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
  Purpose
This phase II trial is studying cisplatin or nedaplatin combine with IMRT to evaluate which one is better efficacy and security in nasopharyngeal carcinoma.

Condition Intervention Phase
Nasopharyngeal Carcinoma Drug: Cisplatin Drug: Nedaplatin Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study to Evaluate Efficacy and Safety of Intensity-modulated Radiation Therapy Combined With Cisplatin or Nedaplatin Chemotherapy in Patients With Nasopharyngeal Carcinoma

Resource links provided by NLM:


Further study details as provided by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University:

Primary Outcome Measures:
  • locoregionally control rate [ Time Frame: 3 months ]
    3 months after treatment


Secondary Outcome Measures:
  • Survival [ Time Frame: 1,3,5 years ]
    1 year Progress Free Survival,Disease Free Survival,3 years and 5 years Over All Survival,Safety


Estimated Enrollment: 20
Study Start Date: January 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cisplatin
cisplatin combine with IMRT
Drug: Cisplatin
40mg/m2/w
Experimental: Nedaplatin
Nedaplatin combine with IMRT
Drug: Nedaplatin
40mg/m2/w

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Age≥18,T1-2aN1-3;T2-4NxNPC,VEGFR+,++,KPS>70,Life expectancy≥6 months, No uncontrolled hypertension,cardiac failure,diabetes,lunacy

Exclusion Criteria:

Distant metastasis, recurrent disease

  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): NCT01265147


Contacts
Contact: Zhenzhou Yang, Dr. 86(23)68757182 yangzhenzhou@sohu.com

Locations
China
Daping Hospital Not yet recruiting
Chong Qing, China
Contact: Zhenzhou Yang, Dr.         
Principal Investigator: Zhenzhou Yang, Dr.         
Sponsors and Collaborators
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
  More Information

Responsible Party: Zhenzhou Yang, Daping Hospital
ClinicalTrials.gov Identifier: NCT01265147     History of Changes
Other Study ID Numbers: Daping H 001
First Submitted: December 3, 2010
First Posted: December 23, 2010
Last Update Posted: January 20, 2011
Last Verified: November 2010

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
Cisplatin
Antineoplastic Agents