Randomised Phase II Pilot Studiy: Induction Chemotherapy with Docetaxel, Cisplatin und Cetuximab versus Docetaxel, Cisplatin und 5 FU followed by Radiotherapy with Cetuximab for locally advanced or not resectable Carcinoma of the Head and Neck

Phase 1

• Conditions: ocally advanced or not resectable Carcinoma of the Head and Neck; MedDRA version: 20.0Level: LLTClassification code 10041862Term: Squamous cell carcinoma of the oral cavity stage IIISystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10041863Term: Squamous cell carcinoma of the oral cavity stage IVSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10041855Term: Squamous cell carcinoma of the hypopharynx stage IVSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10023860Term: Laryngeal squamous cell carcinoma stage IIISystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10041854Term: Squamous cell carcinoma of the hypopharynx stage IIISystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10023861Term: Laryngeal squamous cell carcinoma stage IVSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-005540-99-AT
• Lead Sponsor: AGMT – Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-22
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

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 syndrom or othe clinically significant cardiovascular diseases

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Response Rate (CR, PR) 3 months after end of therapy (RECIST);Secondary Objective: Overall Pesponse Rate (CR, PR, PD, SD) (RECIST)<br>Locoregionally monitoring after one year <br>Progression Free Survival (PFS) and Overall-Survival 1, 2 and 5 years after start of therapy<br>Toxicity:<br>- Acute toxicity within 3 months after end of radiotherapy<br>- Late toxicity: till 60 months after end of radiotherapy<br>;Primary end point(s): Response Rate (CR, PR) 3 months after end of therapy (RECIST);Timepoint(s) of evaluation of this end point: „Last patient in expected in June 2014, <br>3 months after end of therapy - Last patient out” (therapy) expectet in December 2014

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Overall Pesponse Rate (CR, PR, PD, SD) (RECIST)<br>Locoregionally monitoring after one year <br>Progression Free Survival (PFS) and Overall-Survival 1, 2 and 5 years after start of therapy<br>Toxicity:<br>- Acute toxicity within 3 months after end of radiotherapy<br>- Late toxicity: till 60 months after end of radiotherapy<br>;Timepoint(s) of evaluation of this end point: End of study: LPLV 60 months after start of therapy of last patient (anticipated June 2019)