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A Post Marketing Surveillance Study to Assess the Safety and Efficacy of Cetuximab Plus Radiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck

NCT01303237 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 88

Last updated 2017-06-09

No results posted yet for this study

Summary

This prospective, observational, multicentre, post marketing surveillance study will collect safety and efficacy information on patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck (LA SCCHN) treated with Cetuximab and Radiotherapy (RT) based on the locally approved label.

Conditions

  • Unresectable Locally Advanced Squamous Cell Carcinoma of Head and Neck
  • LA SCCHN

Interventions

DRUG

Cetuximab + RT

Cetuximab initial dose 400 mg/m² on week 1; Cetuximab maintenance dose 250 mg/m² continued for 7 weeks plus concomitant RT

Sponsors & Collaborators

  • Merck Ltd., India

    collaborator INDUSTRY

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Rajiv Rana, MD · Merck Ltd., India

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-06-30
Completion
2014-08-05

Countries

  • India

Study Locations

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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 NCT01303237 on ClinicalTrials.gov