LUX-Head&Neck 2: A Phase III Trial of Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy
- Registration Number
- NCT01345669
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-radiotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 617
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Afatinib (BIBW 2992) Afatinib Once daily Placebo Placebo Once daily
- Primary Outcome Measures
Name Time Method Disease Free Survival (DFS) Up to 5 years Disease Free Survival defined as the time from randomisation until documented tumour recurrence/ second primary tumour (SPT) or death from any cause, whichever occurred first.
- Secondary Outcome Measures
Name Time Method Disease Free Survival (DFS) Rate at 2 Years Up to 2 years Disease Free Survival (DFS) rate at 2 years. Probability of being disease free at 2 years in percentage is provided based on Kaplan-Meier method.
Percentage of Patient Deaths (Overall Survival (OS)) Up to 5 years Overall survival (OS), defined as the time from randomisation until death (regardless of cause). Due to the small event rate in both treatment arms caused by the early termination of the trial, the hazard estimate is not interpretable. Hence presented the total randomized and the percentage of patients died.
Patients With Improved Health Related Quality of Life (HRQOL) Up to 5 years HRQoL questionnaires focused on 3 scales: Pain scale from H\&N35, Swallowing scale from H\&N35 and Global health status/QoL scale from C30. Improvement was defined as a score that improved from baseline by at least 10 points (on the 0-100 point scale) at any time during the study. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the study. Patients who had neither improved nor worsened were considered as stable. Percentages of patients with improvement in HRQoL are presented.
Time to Deterioration in Health Related Quality of Life (HRQOL) Up to 5 years HRQoL questionnaires focused on 3 scales: Pain scale from H\&N35, Swallowing scale from H\&N35 and Global health status/QoL scale from C30. Time to deterioration was defined as the time from randomisation to the first 10-point worsening on the 0-100 point scale. Patients with no deterioration (including those with disease recurrence/SPT) were censored at the last available HRQoL assessment date. Patients with no post-baseline assessments were censored on the day of randomisation.
Health Related Quality of Life (HRQOL) Scores Over Time Baseline and 5 years HRQoL questionnaires focused on 3 scales: Pain scale from H\&N35, Swallowing scale from H\&N35 and Global health status/QoL scale from C30. Scoring of the symptom scales/items followed the European Organisation for Research and Treatment of Cancer (EORTC) scoring manual and a linear transformation of the scores to a 0-100 point scale. Higher values are better.
Trial Locations
- Locations (162)
1200.131.00171 Boehringer Ingelheim Investigational Site
🇺🇸Little Rock, Arkansas, United States
1200.131.00181 Boehringer Ingelheim Investigational Site
🇺🇸Orange, California, United States
1200.131.00177 Boehringer Ingelheim Investigational Site
🇺🇸Aurora, Colorado, United States
1200.131.00185 Boehringer Ingelheim Investigational Site
🇺🇸New Haven, Connecticut, United States
1200.131.00173 Boehringer Ingelheim Investigational Site
🇺🇸Baltimore, Maryland, United States
1200.131.00176 Boehringer Ingelheim Investigational Site
🇺🇸Boston, Massachusetts, United States
1200.131.00182 Boehringer Ingelheim Investigational Site
🇺🇸Omaha, Nebraska, United States
1200.131.00175 Boehringer Ingelheim Investigational Site
🇺🇸Lebanon, New Hampshire, United States
1200.131.00179 Boehringer Ingelheim Investigational Site
🇺🇸Stony Brook, New York, United States
1200.131.00188 Boehringer Ingelheim Investigational Site
🇺🇸The Bronx, New York, United States
Scroll for more (152 remaining)1200.131.00171 Boehringer Ingelheim Investigational Site🇺🇸Little Rock, Arkansas, United States