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

January 19, 2011 updated by: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Phase II Study to Evaluate Efficacy and Safety of Intensity-modulated Radiation Therapy Combined With Cisplatin or Nedaplatin Chemotherapy in Patients With Nasopharyngeal Carcinoma

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Chong Qing, China
        • Daping Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cisplatin
cisplatin combine with IMRT
Drug: Cisplatin
40mg/m2/w
Experimental: Nedaplatin
Nedaplatin combine with IMRT
Drug: Nedaplatin
40mg/m2/w

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
locoregionally control rate
Time Frame: 3 months
3 months after treatment
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 1,3,5 years
1 year Progress Free Survival,Disease Free Survival,3 years and 5 years Over All Survival,Safety
1,3,5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

December 3, 2010

First Submitted That Met QC Criteria

December 22, 2010

First Posted (Estimate)

December 23, 2010

Study Record Updates

Last Update Posted (Estimate)

January 20, 2011

Last Update Submitted That Met QC Criteria

January 19, 2011

Last Verified

November 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Daping H 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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