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
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|ClinicalTrials.gov Identifier: NCT01345669|
Recruitment Status : Terminated
First Posted : May 2, 2011
Results First Posted : October 23, 2017
Last Update Posted : December 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Neoplasms||Drug: Placebo Drug: Afatinib||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||617 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomised, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Afatinib (BIBW 2992) as Adjuvant Therapy After Chemo-radiotherapy in Primary Unresected Patients With Stage III, IVa, or IVb Loco-regionally Advanced Head and Neck Squamous Cell Carcinoma|
|Actual Study Start Date :||October 17, 2011|
|Actual Primary Completion Date :||September 12, 2016|
|Actual Study Completion Date :||September 12, 2016|
Experimental: Afatinib (BIBW 2992)
Placebo Comparator: Placebo
- Disease Free Survival (DFS) [ Time Frame: 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.
- Disease Free Survival (DFS) Rate at 2 Years [ Time Frame: 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)) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01345669
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|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|