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

Primary Purpose

Nasopharyngeal Carcinoma

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Nedaplatin
Cisplatin
Sponsored by
He Xia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Low dose cisplatin arm

    High dose cisplatin arm

    Low dose nedaplatin arm

    High dose nedaplatin arm

    Arm Description

    concurrent chemotherapy: cisplatin 20mg/m2,weekly,for 6 cycles during radiotherapy

    concurrent chemotherapy: cisplatin 30mg/m2,weekly,for 6 cycles during radiotherapy

    concurrent chemotherapy: nedaplatin 20mg/m2,weekly,for 6 cycles during radiotherapy

    concurrent chemotherapy: nedaplatin 30mg/m2,weekly,for 6 cycles during radiotherapy

    Outcomes

    Primary Outcome Measures

    Response rate
    Progress-free survival

    Secondary Outcome Measures

    Tumor response
    Overall survival

    Full Information

    First Posted
    November 19, 2014
    Last Updated
    December 5, 2014
    Sponsor
    He Xia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02301208
    Brief Title
    Weekly Cisplatin or Nedaplatin Concurrent With Intensity-modulated Radiation Therapy in Nasopharyngeal Carcinoma
    Acronym
    NPC-RCT-WCRT
    Official Title
    A Randomized Phase III Study of Concurrent Weekly Nedaplatin or Cisplatin With IMRT in NPC Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2014 (undefined)
    Primary Completion Date
    December 2016 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    He Xia

    4. Oversight

    5. Study Description

    Brief Summary
    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).

    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 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Low dose cisplatin arm
    Arm Type
    Active Comparator
    Arm Description
    concurrent chemotherapy: cisplatin 20mg/m2,weekly,for 6 cycles during radiotherapy
    Arm Title
    High dose cisplatin arm
    Arm Type
    Active Comparator
    Arm Description
    concurrent chemotherapy: cisplatin 30mg/m2,weekly,for 6 cycles during radiotherapy
    Arm Title
    Low dose nedaplatin arm
    Arm Type
    Experimental
    Arm Description
    concurrent chemotherapy: nedaplatin 20mg/m2,weekly,for 6 cycles during radiotherapy
    Arm Title
    High dose nedaplatin arm
    Arm Type
    Experimental
    Arm Description
    concurrent chemotherapy: nedaplatin 30mg/m2,weekly,for 6 cycles during radiotherapy
    Intervention Type
    Drug
    Intervention Name(s)
    Nedaplatin
    Other Intervention Name(s)
    NDP
    Intervention Description
    Nedaplatin combine with IMRT
    Intervention Type
    Drug
    Intervention Name(s)
    Cisplatin
    Other Intervention Name(s)
    PDD, DDP, CDDP
    Intervention Description
    Cisplatin combine with IMRT
    Primary Outcome Measure Information:
    Title
    Response rate
    Time Frame
    2 years
    Title
    Progress-free survival
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Tumor response
    Time Frame
    radiotherapy in 2 week、4 week、7 week
    Title
    Overall survival
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Li Yin, M.D. Ph.D.
    Phone
    +8613913909043
    Email
    yinli7878@sina.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Pengwei Yan, M.M.
    Phone
    +8613815888775
    Email
    179032794@qq.com

    12. IPD Sharing Statement

    Learn more about this trial

    Weekly Cisplatin or Nedaplatin Concurrent With Intensity-modulated Radiation Therapy in Nasopharyngeal Carcinoma

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