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Platinum-Cetuximab Combined With Docetaxel or With 5FU in Patients With Recurrent/Metastatic HNSCC

NCT02268695 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 541

Last updated 2022-08-23

No results posted yet for this study

Summary

This study evaluates the efficacy of the new docetaxel-cisplatin-cetuximab regimen (TPEx) versus the standard platinum-5FU-cetuximab EXTREME regimen as a first-line treatment in recurrent and/or metastatic HNSCC. Half of patients will be treated by TPEx regimen, while the other half will be treated by EXTREME regimen.

Conditions

Interventions

DRUG

Cisplatin

DRUG

5-Fluorouracile

DRUG

Docetaxel

DRUG

Cetuximab

DRUG

granulocyte colony-stimulating factor (G-CSF)

Sponsors & Collaborators

  • Grupo Español de Tratamiento de Tumores de Cabeza y Cuello

    collaborator OTHER

  • AIO-Studien-gGmbH

    collaborator OTHER

  • Groupe Oncologie Radiotherapie Tete et Cou

    lead OTHER

Principal Investigators

  • Joel GUIGAY, MD · Centre Antoine Lacassagne, Nice, France

  • Jean BOURHIS, MD, PhD · GORTEC President

  • Ricardo MESIA, MD · Instituto Catalá de Oncologia (ICO), Barcelona, Spain

  • Ulrich KEILHOLZ, MD · Charité Campus Benjamin Franklin, Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
71 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-10
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • France
  • Germany
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02268695 on ClinicalTrials.gov