NCT00910117

Brief Summary

The aim of the study is to evaluate the role of nimotuzumab in the neo-adjuvant setting in patients with locally advanced HNSCC. The hypothesis is that the response would be increased with the combination of nimotuzumab and cisplatin and fluorouracil (PF) regimen.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_2 head-and-neck-cancer

Timeline
Completed

Started May 2009

Shorter than P25 for phase_2 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 29, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 20, 2012

Status Verified

February 1, 2012

Enrollment Period

2.6 years

First QC Date

May 28, 2009

Last Update Submit

February 16, 2012

Conditions

Head and Neck Cancer

Keywords

HNSCCinduction chemotherapynimotuzumab

Outcome Measures

Primary Outcomes (1)

  • overall response rate

    6 weeks

Secondary Outcomes (1)

  • pathologic complete response

    8 weeks

Study Arms (1)

nimotuzumab

EXPERIMENTAL

nimotuzumab plus PF regimen

Drug: nimotuzumabDrug: PF regimen (cisplatin and 5-FU)

Interventions

nimotuzumabDRUG

nimotuzumab 400 mg d1

Also known as: h-R3
nimotuzumab
PF regimen (cisplatin and 5-FU)DRUG

cisplatin 75 mg/m2 d1 and 5-FU 750 mg/m2/d CIV d1-5

Also known as: PF
nimotuzumab

Eligibility Criteria

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

You may qualify if:

  • Age range 18-70 years old
  • ECOG performance status 0-1
  • Histologically confirmed and potentially resectable locally advanced (T2-4, N0-3, M0) HNSCC
  • Adequate organ function

You may not qualify if:

  • History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  • Pregnant or lactating women
  • Serious uncontrolled diseases and intercurrent infection
  • Previous serious cardiac disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

nimotuzumabCF regimenCisplatinFluorouracil

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ye Guo, MD

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

May 28, 2009

First Posted

May 29, 2009

Study Start

May 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

February 20, 2012

Record last verified: 2012-02

Locations

CN(1)