CompletedPhase 2

Induction Chemotherapy With TP+5-FU or TP+Cetuximab Followed by Radioimmuptherapy for Locally Advanced or Not Resectable SCCHNN

Austria100 participantsStarted 2013-05

Plain-language summary

This multicentre, randomised Phase II Pilot Study evaluates the efficacy of docetaxel, cisplatin and 5-fluorouracil or Cetuximab, followed by Cetuximab with radiotherapy.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histologically confirmed local advanced squamous cell carcinoma of the Larynx, Hypopharynx, Oropharynx or Cavum oris stage III and IV * One measureable lesion (CT oder MR) * Age 18 - 75 (including) * Performance Score ECOG 0 - 1 Exclusion Criteria selected: * Distant metastases * ECOG Score \>1 * Prior radiation (Head and neck area) * Creatinin Clearance below 60 ml/µl * Acute infections * Neuropathy grade 3 or 4 * Myocardial Infarction within the last 12 months * Acute coronary syndrome or othe clinically significant cardiovascular diseases

What they're measuring

Response Rate (CR, PR)

Timeframe: 3 months after end of therapy

Trial details

NCT IDNCT01884259

SponsorArbeitsgemeinschaft medikamentoese Tumortherapie

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-01-28

View on ClinicalTrials.gov More Squamous Cell Carcinoma of the Hypopharynx Stage III trials