Clinical trial · Observational
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was discontinued due to slow recruitment and subjects not completing follow up period.
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| LA SCCHN | — | UNRESOLVED | — |
| Unresectable Locally Advanced Squamous Cell Carcinoma of Head and Neck | Head and Neck Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab + RT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of Patients with Serious Adverse Reactions
- timeFrame
- 3 years
- description
- Number of patients with Serious Adverse Reactions will be assessed to discover the tolerability of the treatment regimen.
Secondary outcomes (6)
- measure
- Response Rate
- timeFrame
- 3 years
- measure
- Progression Free Survival
- timeFrame
- 3 years
- measure
- Duration of Locoregional Disease Control
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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: * Exclusion criteria as per the product label for LA SCCHN approved by India Health Authority
References
Publications (0)
Data not yet available