Induction chemotherapy followed by chemoradiation with cetuximab and cisplatin for inoperable squamous cell carcinoma of the head and neck.

• Conditions: Inoperable squamous cell carcinoma of the head and neck.

• Registration Number: EUCTR2006-003381-33-SI
• Lead Sponsor: Institute of Oncology Ljubljana

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Squamous cell carcinoma, histologically proven.
- Tumor site: oral cavity, oropharynx, hypopharynx, or larynx.
- Locally and/or regionally inoperable tumors (UICC TNM stages IVa or IVb), without distant metastases (M0-stage); criteria for inoperability:
--> Technical unresectability,
--> Tumor fixation to the clavicle, base of skull or the cervical vertebrae,
--> Involvement of the nasopharynx or carotid artery.
- Declaration of the inoperability of the patient given by a head and neck surgeon and radiation oncologist at the multidisciplinary tumor conference.
- Male or female =18 years of age.
- Expected survival > 6 months.
- Presence of at least one bidimensionally measurable index lesion.
- Effective contraception for both male and female subjects if risk of conception exists.
- WHO performance status 0-2
- Laboratory parameters:
--> hemoglobin =100 g/L
--> leukocyte count > 3,5×109/L, absolute neutrophil count =1,5×109/L
--> platelet count > 100×109/L
--> total bilirubin < 1,25×upper normal limit
--> transaminases (ALT, AST) < 5×upper normal limit
--> creatinine clearance =55 ml/minute.
- Signed written 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Metastatic disease.
- Squamous cell carcinoma of the nasopharynx and nasal cavity and paranasal sinuses.
- ChT or XRT ineligibility:
--> Unstable cardiac disease or any other medical condition likely to compromise the safe delivery of ChT or XRT;
--> Clinically evident hearing impairment;
--> Pre-existing motor or sensory neurotoxicity grade = 2 according to the CTCAE v3.0.
- Any kind of previous therpay for SCCHN (excluding diagnostic biopsy).
- Previous administration of EGFR pathway-tergeting therapy.
- Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy which is not part of the study protocol.
- Participation in another clinical trial within 30 days prior to study entry.
- Pregnancy or breast feeding.
- History of severe acute pulmonary disease.
- Any investigational agent within past 30 days.
- Other previous malignancy within 5 years, with exception of a history of a previously adequately treated basal call carcinoma of the skin or pre-invasive carcinoma of the cervix.
- Known drug abuse / severe alcohol abuse.
- Legal incapacity or limited legal capacity.
- Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent.
- Active, uncontrolled infection.
- Other medical condition or other therapy that in the opinion of the investigator precludes the safe administration of the planned ChT and XRT.

Study & Design

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