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

Primary Purpose

Nasopharyngeal Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Cisplatin
Nedaplatin
Sponsored by
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Daping Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cisplatin

Nedaplatin

Arm Description

cisplatin combine with IMRT

Nedaplatin combine with IMRT

Outcomes

Primary Outcome Measures

locoregionally control rate
3 months after treatment

Secondary Outcome Measures

Survival
1 year Progress Free Survival,Disease Free Survival,3 years and 5 years Over All Survival,Safety

Full Information

First Posted
December 3, 2010
Last Updated
January 19, 2011
Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01265147
Brief Title
Intensity-modulated Radiation Therapy Combined With Cisplatin or Nedaplatin Chemotherapy in Nasopharyngeal Carcinoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cisplatin
Arm Type
Active Comparator
Arm Description
cisplatin combine with IMRT
Arm Title
Nedaplatin
Arm Type
Experimental
Arm Description
Nedaplatin combine with IMRT
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
40mg/m2/w
Intervention Type
Drug
Intervention Name(s)
Nedaplatin
Intervention Description
40mg/m2/w
Primary Outcome Measure Information:
Title
locoregionally control rate
Description
3 months after treatment
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Survival
Description
1 year Progress Free Survival,Disease Free Survival,3 years and 5 years Over All Survival,Safety
Time Frame
1,3,5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenzhou Yang, Dr.
Phone
86(23)68757182
Email
yangzhenzhou@sohu.com
Facility Information:
Facility Name
Daping Hospital
City
Chong Qing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenzhou Yang, Dr.
First Name & Middle Initial & Last Name & Degree
Zhenzhou Yang, Dr.

12. IPD Sharing Statement

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

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