Afatinib (BIBW 2992) versus placebo after chemo-radiotherapy to patients with head and neck cancer
- Conditions
- oco-regionally advanced head and head squamous cell carcinoma with no evidence of disease after chemo-radiotherapyMedDRA version: 18.1Level: PTClassification 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-PT
- Lead Sponsor
- nilfarma, Lda.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 669
•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 (e.g. 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 24 weeks prior to randomisation. At randomisation, chemo-radiotherapy induced side effects CTCAE grade = 2
•No evidence of disease (NED), defined as no measurable or palpable tumour on clinical and radiographic (e.g. CT scan or MRI) examinations as judged by the investigator in either of the following:
a) No residual tumour after CRT
b) No residual tumour after CRT followed by R0 tumour resection
c) No evidence of nodal disease after CRT followed by neck dissection.
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
•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
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the efficacy of afatinib over placebo when given as adjuvant therapy after chemo-radiotherapy (CRT) in primary unresected patients with loco-regionally advanced squamous cell carcinoma stage III or IVa/b of the oral cavity, oropharynx, or hypopharynx, or larynx stage IVa/b;Secondary Objective: To investigate the safety of afatinib over placebo when given as adjuvant therapy after chemo-radiotherapy (CRT) in primary unresected patients with loco-regionally advanced squamous cell carcinoma stage III or IVa/b of the oral cavity, oropharynx, or hypopharynx, or larynx stage IVa/b;Primary end point(s): Disease Free Survival (DFS);Timepoint(s) of evaluation of this end point: Approximately 4 years
- Secondary Outcome Measures
Name Time Method Secondary end point(s): DFS rate at 2 years<br>Overall Survival (OS)<br>Health Related Quality of Life (HRQOL)<br>Adverse Events;Timepoint(s) of evaluation of this end point: Approximately 4 years