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Determination of Cetuximab Versus Cisplatin Early and Late Toxicity Events in HPV+ OPSCC

NCT01874171 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2017-05-08

No results posted yet for this study

Summary

Oropharyngeal squamous cell carcinoma (OPSCC) incidence is increasing rapidly in the developed world. This has been attributed to a rise in Human Papillomavirus (HPV) infection. HPV+OPSCC is considered a distinct disease entity, affecting younger patients and has a good prognosis following treatment. Subsequently, patients can live with the considerable side effects for several decades.

Radiotherapy and cetuximab (Epidermal Growth Factor Receptor-inhibitor) have demonstrated similar efficacy to 'platin' chemoradiotherapy (current standard treatment containing platinum-based compounds) in head and neck cancer, but is potentially less toxic.

Results of this trial will be used to determine the optimum treatment of this debilitating cancer, with the primary aim of decreasing toxicity and improving quality of life for HPV+OPSCC patients.

Conditions

  • Oropharyngeal Squamous Cell Carcinoma

Interventions

DRUG

Cisplatin

DRUG

Cetuximab

Sponsors & Collaborators

  • Cancer Research UK

    collaborator OTHER

  • University of Birmingham

    collaborator OTHER

  • University of Oxford

    collaborator OTHER

  • University of Warwick

    lead OTHER

Principal Investigators

  • Hisham Mehanna, PhD, BMedSc (hons), FRCS · University of Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-15
Primary Completion
2019-02-28
Completion
2019-02-28

Countries

  • Ireland
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT01874171 on ClinicalTrials.gov