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

• Status: Active, not recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Treatments: Cetuximab; Cisplatin; Docetaxel; Fluorouracil

Criteria

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