NCT02301208

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).

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2014

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

December 8, 2014

Status Verified

December 1, 2014

Enrollment Period

2 years

First QC Date

November 19, 2014

Last Update Submit

December 5, 2014

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Response rate

    2 years

  • Progress-free survival

    2 years

Secondary Outcomes (2)

  • Tumor response

    radiotherapy in 2 week、4 week、7 week

  • Overall survival

    2 years

Study Arms (4)

Low dose cisplatin arm

ACTIVE COMPARATOR

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

Drug: Cisplatin

High dose cisplatin arm

ACTIVE COMPARATOR

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

Drug: Cisplatin

Low dose nedaplatin arm

EXPERIMENTAL

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

Drug: Nedaplatin

High dose nedaplatin arm

EXPERIMENTAL

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

Drug: Nedaplatin

Interventions

NedaplatinDRUG

Nedaplatin combine with IMRT

Also known as: NDP
High dose nedaplatin armLow dose nedaplatin arm
CisplatinDRUG

Cisplatin combine with IMRT

Also known as: PDD, DDP, CDDP
High dose cisplatin armLow dose cisplatin arm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

nedaplatinCisplatin

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Central Study Contacts

Li Yin, M.D. Ph.D.

CONTACT

+8613913909043yinli7878@sina.com

Pengwei Yan, M.M.

CONTACT

+8613815888775179032794@qq.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Jiangsu Cancer Hospital

Study Record Dates

First Submitted

November 19, 2014

First Posted

November 25, 2014

Study Start

December 1, 2014

Primary Completion

December 1, 2016

Last Updated

December 8, 2014

Record last verified: 2014-12