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

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 (LA SCCHN)

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01303237

Acronym

PMS LAD SCCHN

Enrollment

Registered

2011-02-24

Start date

2011-02-28

Completion date

2014-08-05

Last updated

2017-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

LA SCCHN, Cetuximab, RT, PMS

Brief 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.

Detailed description

This is a prospective, non-randomized, observational, single arm, cohort study, wherein 200 patients of unresectable LA SCCHN will be enrolled. The eligibility of the patients will be decided by the Investigators based on the locally approved label. The patients will be treated with Cetuximab in combination with RT for a duration of 8 weeks and then followed up for 3 years. The objectives of this study are to record safety and efficacy information on the treatment combination in the general population.

Interventions

DRUGCetuximab + RT

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Inclusion criteria as per the product label for LA SCCHN approved by India Health Authority * Unresectable Locally Advanced Squamous Cell Carcinoma of the Head and Neck * Patient willing and able to give written Informed Consent * Patient capable of complying with study data collection procedures

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Number of Patients with Serious Adverse Reactions	3 years	Number of patients with Serious Adverse Reactions will be assessed to discover the tolerability of the treatment regimen.

Secondary

Measure	Time frame
Response Rate	3 years
Progression Free Survival	3 years
Duration of Locoregional Disease Control	3 years
Overall Survival	3 years
Management of skin conditions due to treatment protocol	3 years

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026