MedTrace Logo

Skin Changes in Head and Neck Cancer During Immuno-(Chemo-) And Radiotherapy With Erbitux® (HICARE)

NCT01553032 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2022-05-25

No results posted yet for this study

Summary

This is a national multicenter phase IV study to assess acute radiation dermatitis of combined radioimmuno(chemo)therapy with Cetuximab in patients with locally advanced, non-metastatic squamous cell carcinoma of the head and neck (LASCCHN).

Conditions

Interventions

DRUG

Erbitux®

400mg/m2 initial dose, followed by weekly doses of 250mg/m2 Treatment duration: 7-8 weeks

RADIATION

Fractionated Radiotherapy

30-35 fractions of radiotherapy (6-7 weeks)

Sponsors & Collaborators

  • iOMEDICO AG

    collaborator INDUSTRY

  • University of Heidelberg Medical Center

    lead OTHER

Principal Investigators

  • Jürgen Debus, Prof. Dr. Dr · University Heidelberg, Klinik für Radioonkologie und Strahlentherapie, Im Neuenheimer Feld 400, 69120 Heidelberg

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

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 NCT01553032 on ClinicalTrials.gov