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Study of Post-Op Adjuvant Concurrent Chemo-RT With or Without Nimotuzumab for Head & Neck Cancer

NCT00957086 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 710

Last updated 2024-01-09

No results posted yet for this study

Summary

The aim of the study is to improve the loco-regional control rate and overall survival of locally advanced head and neck squamous carcinoma (HNSCC). The investigators hypothesize that the addition of nimotuzumab (a recombinant humanized murine immune antibody that blocks both epidermal growth factor (EGF) and transforming growth factor (TGF)) to the current gold standard of concurrent chemoradiotherapy (CCRT) (7)(8), an adjuvant setting in patients after resection of their locally advanced HNSCC will confer therapeutic advantage.

Conditions

  • Carcinoma, Squamous Cell of Head and Neck

Interventions

DRUG

Nimotuzumab

Administered by intravenous infusion at 200 mg absolute per dose, diluted in 250 ml of sodium chloride over 30 minutes. 8 weekly doses of study drug will be given, beginning on first week of radiotherapy.

DRUG

Placebo

Administered by intravenous infusion at 200 mg absolute per dose, diluted in 250 ml of sodium chloride over 30 minutes. 8 weekly doses of study drug will be given, beginning on first week of radiotherapy.

Sponsors & Collaborators

  • National Medical Research Council (NMRC), Singapore

    collaborator OTHER_GOV

  • Innogene Kalbiotech Pte. Ltd

    collaborator INDUSTRY

  • National Cancer Centre, Singapore

    lead OTHER

Principal Investigators

  • K C Soo, Prof · National Cancer Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-13
Primary Completion
2025-01-01
Completion
2025-01-01

Countries

  • Australia
  • Cuba
  • Egypt
  • India
  • Indonesia
  • Malaysia
  • Philippines
  • Saudi Arabia
  • Singapore
  • South Africa
  • South Korea
  • Taiwan
  • Thailand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00957086 on ClinicalTrials.gov