A four-arm randomized study comparing two different drugs as well as two different radiotherapy techniques

• Conditions: ocally advanced squamous cell cancer of the Head and Neck; MedDRA version: 14.1Level: PTClassification code 10071537Term: Head and neck cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10071536Term: Head and neck cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000437-39-NL
• Lead Sponsor: ederlands Kanker Instituut/Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-27
• Last Update Posted: 15 May 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 268

Inclusion Criteria

- Squamous cell carcinoma of the oropharynx, oral cavity or hypopharynx
- Stage III-IV, T3-4, Nx M0
- Age 18 to 70 yrs
- GFR >60
- informed consent

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 168
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

- Inability to undergo any one of the treatment arms
- Laryngeal cancer
- Known active symptomatic infections
- Prior surgery, radiotherapy or chemotherapy for this tumour

Study & Design

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