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NCT01265147 Clinical Trial

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

Nasopharyngeal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01265147
Other study ID # Daping H 001
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received December 3, 2010
Last updated January 19, 2011
Start date January 2011
Est. completion date December 2017

Study information
Verified date November 2010
Source Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Contact Zhenzhou Yang, Dr.
Phone 86(23)68757182
Email yangzhenzhou@sohu.com
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This phase II trial is studying cisplatin or nedaplatin combine with IMRT to evaluate which one is better efficacy and security in nasopharyngeal carcinoma.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date December 2017
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Cisplatin
40mg/m2/w
• Nedaplatin
40mg/m2/w

Locations
Country Name City State
China Daping Hospital Chong Qing

Sponsors (1)
Lead Sponsor Collaborator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary locoregionally control rate 3 months after treatment 3 months No
Secondary Survival 1 year Progress Free Survival,Disease Free Survival,3 years and 5 years Over All Survival,Safety 1,3,5 years Yes
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