Weekly Cisplatin or Nedaplatin Concurrent With Intensity-modulated Radiation Therapy in Nasopharyngeal Carcinoma (NPC-RCT-WCRT)

December 5, 2014 updated by: He Xia

A Randomized Phase III Study of Concurrent Weekly Nedaplatin or Cisplatin With IMRT in NPC Patients

This is a randomized Phase III study to evaluate efficancy of weekly cisplatin or nedaplatin concurrent with Intensity-modulated radiation therapy in Nasopharyngeal Carcinoma (NPC).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

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

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pathologically confirmed untreated NPC patients
  • T1-2N1-3M0 or T3-4NxM0
  • 18-70 years old
  • with MRI examinations
  • ECOG ≤ 2
  • With written consent

Exclusion Criteria:

  • With a second cancer
  • Pregnancy
  • With other severe diseases (blood,liver ,kidney or heart diseases)
  • Could not be staged properly
  • Without written consent

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low dose cisplatin arm
concurrent chemotherapy: cisplatin 20mg/m2,weekly,for 6 cycles during radiotherapy
Drug: Cisplatin
Cisplatin combine with IMRT
Other Names:
  • CDDP
  • DDP
  • PDD
Active Comparator: High dose cisplatin arm
concurrent chemotherapy: cisplatin 30mg/m2,weekly,for 6 cycles during radiotherapy
Drug: Cisplatin
Cisplatin combine with IMRT
Other Names:
  • CDDP
  • DDP
  • PDD
Experimental: Low dose nedaplatin arm
concurrent chemotherapy: nedaplatin 20mg/m2,weekly,for 6 cycles during radiotherapy
Drug: Nedaplatin
Nedaplatin combine with IMRT
Other Names:
  • NDP
Experimental: High dose nedaplatin arm
concurrent chemotherapy: nedaplatin 30mg/m2,weekly,for 6 cycles during radiotherapy
Drug: Nedaplatin
Nedaplatin combine with IMRT
Other Names:
  • NDP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate
Time Frame: 2 years
2 years
Progress-free survival
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 2 years
2 years
Tumor response
Time Frame: radiotherapy in 2 week、4 week、7 week
radiotherapy in 2 week、4 week、7 week

Collaborators and Investigators

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

Sponsor

He Xia

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

December 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

November 19, 2014

First Submitted That Met QC Criteria

November 21, 2014

First Posted (Estimate)

November 25, 2014

Study Record Updates

Last Update Posted (Estimate)

December 8, 2014

Last Update Submitted That Met QC Criteria

December 5, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JiangsuCIH

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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