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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2010 by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor:
Information provided by:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
ClinicalTrials.gov Identifier:
NCT01265147
First received: December 3, 2010
Last updated: January 19, 2011
Last verified: November 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    3 months after treatment


Secondary Outcome Measures:
  • Survival [ Time Frame: 1,3,5 years ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Zhenzhou Yang, Daping Hospital
ClinicalTrials.gov Identifier: NCT01265147     History of Changes
Other Study ID Numbers: Daping H 001
Study First Received: December 3, 2010
Last Updated: January 19, 2011
Health Authority: China: Food and Drug Administration

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
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 14, 2014