NCT01265147

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

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

December 3, 2010

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 23, 2010

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 20, 2011

Status Verified

November 1, 2010

Enrollment Period

1.9 years

First QC Date

December 3, 2010

Last Update Submit

January 19, 2011

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

  • locoregionally control rate

    3 months after treatment

    3 months

Secondary Outcomes (1)

  • Survival

    1,3,5 years

Study Arms (2)

Cisplatin

ACTIVE COMPARATOR

cisplatin combine with IMRT

Drug: Cisplatin

Nedaplatin

EXPERIMENTAL

Nedaplatin combine with IMRT

Drug: Nedaplatin

Interventions

CisplatinDRUG

40mg/m2/w

Cisplatin
NedaplatinDRUG

40mg/m2/w

Nedaplatin

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age≥18,T1-2aN1-3;T2-4NxNPC,VEGFR+,++,KPS\>70,Life expectancy≥6 months, No uncontrolled hypertension,cardiac failure,diabetes,lunacy

You may not qualify if:

  • Distant metastasis, recurrent disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daping Hospital

Chongqing, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Cisplatinnedaplatin

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

Zhenzhou Yang, Dr.

CONTACT

86(23)68757182yangzhenzhou@sohu.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 3, 2010

First Posted

December 23, 2010

Study Start

January 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2017

Last Updated

January 20, 2011

Record last verified: 2010-11

Locations

CN(1)