Afatinib (BIBW 2992) versus placebo after chemo-radiotherapy to patients with head and neck cancer

Phase 1

• Conditions: oco-regionally advanced head and head squamous cell carcinoma with no evidence of disease after chemo-radiotherapy; 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: EUCTR2011-000392-14-ES
• Lead Sponsor: Boehringer Ingelheim España, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-30
• Last Update Posted: 10 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 669

Inclusion Criteria

?Histologically or cytologically confirmed loco-regionally advanced squamous cell carcinoma, stage III, IVa, or IVb, of the oral cavity, oropharynx, or hypopharynx, or larynx stage IVa or IVb
?Unresected tumour prior to chemo-radiotherapy due to:
oTechnical unresectability (tumour fixation/invasion to either base of the skull, cervical vertebrae, nasopharynx, or fixed lymph nodes); and/or
oLow surgical curability (T3-T4, N2-N3 excluding T1N2); and/or
oOrgan preservation
?Concomitant platinum-based chemo-radiotherapy (for minimum requirements see the protocol) completed no longer than 16 weeks prior to randomisation. At randomisation, chemo-radiotherapy induced side effects CTCAE grade ? 2
?Within 16 weeks after concomitant platinum-based CRT, no evidence of disease (NED), defined as no residual tumour, i.e. no measurable or palpable tumour on clinical and radiographic (e.g. CT scan or MRI) examinations as judged by the investigator. In case of palpable mass, NED must be confirmed by biopsy
?ECOG performance status 0 or 1 at the time of randomisation
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 619
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

?Patients with smoking history of ? 10 pack years and with primary tumour site base of tongue
?Patients with smoking history of ? 10 pack years and with primary tumour site tonsil
?Primary cancer of nasopharynx, sinuses, or salivary glands
?Prior treatment with EGFR-targeted small molecules, EGFR-targeted antibodies, and/or any investigational agents for treatment of HNSCC

Study & Design

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