X-Head & Neck 2;A randomised, double-blind, placebo-controlled, phase III study to evaluate the efficacy and safety of afatinib (BIBW 2992) as adjuvant therapy after chemoradiotherapy in primary unresected patients with stage III, IVa, or IVb loco-regionally advanced head and neck squamous cell carcinoma
- Conditions
- head and neck cancersquamous cell carcinoma of the head and neck10072990
- Registration Number
- NL-OMON39253
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 21
*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:;o Technical unresectability (e.g. tumour fixation/invasion to either base of the skull, cervical vertebrae, nasopharynx, or fixed lymph nodes); and/or;
o Low surgical curability (T3-T4, N2-N3 excluding T1N2); and/or;
o Organ 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
-Exclusion 1 is deleted with amendment 2 (protocol revision 03)
-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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint of this trial is Disease Free Survival (DFS), defined as<br /><br>the time from<br /><br>randomisation until recurrence of tumour or death of any cause, whichever<br /><br>occurs first.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoints<br /><br>DFS rate at 2 years<br /><br>Overall survival (OS), defined as the time from randomisation until death<br /><br>(irrespective of reason)<br /><br>Health related quality of life (HRQOL)</p><br>