A clinical Phase I/II-study of radiation therapy (HART(hyperfractionated-accelerated radiation)) plus chemotherapy (cetuximab (CET) and cisplatin (CIS)) in locally advanced inoperable skin cancers of head and neck.

Phase 1

Conditions: Squamous cell cancer of head and neck, unresectable, locally advanced, Stage III/IVa or b (UICC, 2002)
MedDRA version: 14.0Level: LLTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2005-000355-15-DE

Lead Sponsor: Martin-Luther-Universität Halle-Wittenberg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 86

Inclusion Criteria

•Patients with histologically confirmed unresectable SCC of the oral cavity (no lip), oropharynx, hypopharynx or larynx (stage III/IVa or b)
•Unidimensionally measurable lesion
•Signed informed consent
•Karnofsky PS = 70%
•Age = 18 and = 70
•Curative treatment intent
•Negative serum or urine pregnancy test (women of childbearing potential)
•Adaequate bone marrow, hepatic and renal function
(for further details see section 5 study protocol)

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 86
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 86

Exclusion Criteria

•Unknown primary cancer, nasopharynx cancer or salivary gland cancer
•Metastatic disease
•Another cancer within 5 years of study entry
•Serious concomitant disease or medical condition
•Pregnancy or lactation
•Women of child-bearing potential with unclear contraception
•Previous treatment with chemotherapy, radiotherapy or surgery in head and neck
•Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study screening
•Life expectancy < 3 months
•Contraindications to receive cisplatin or cetuximab
•Previous exposure to monoclonal antibodies and/or EGFR-targeted therapy
•Social situations that limit the compliance with study requirements
(for further details see section 5 study protocol)