LUX-Head & Neck 4: 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: NCT02131155|
Recruitment Status : Terminated
First Posted : May 6, 2014
Results First Posted : March 1, 2019
Last Update Posted : March 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Neoplasms||Drug: Placebo Drug: Afatinib||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 :||July 17, 2014|
|Actual Primary Completion Date :||August 22, 2016|
|Actual Study Completion Date :||August 22, 2016|
Experimental: Afatinib (BIBW2992)
Placebo Comparator: Placebo
- Disease Free Survival (DFS) [ Time Frame: up to 4 years ]
DFS, defined as the number of days from the date of randomisation to the date of tumour recurrence/ Second Primary Tumours (SPT) or death from any cause, whichever occurred first.
For patients with known date of tumour recurrence/SPT (or death), the event date was the date of tumour recurrence/SPT or the date of death, whichever came first, i.e.
DFS [day] = minimum (date of tumour recurrence/SPT, date of death) - date of randomisation +1.
For patients known to be alive and without tumour recurrence/SPT by the end of trial or follow-up visit, they were censored at the date of last imaging when the patient was known to be disease-free and alive:
DFS (censored) [days] = date of last imaging when the patient was known to be diseasefree and alive - date of randomisation + 1. The Kaplan-Meier (KM) method was to be used to estimate the median DFS for each treatment group. 95% confidence interval (CI) was to be constructed using the Greenwood variance estimate.
- Disease Free Survival (DFS) Rate at 2 Years [ Time Frame: up to 2 years ]Disease Free Survival (DFS) rate at 2 years is presented
- Overall Survival (OS) [ Time Frame: up to 4 years ]
OS was defined as time from the date of randomisation until death.
For patients with known date of death (regardless of the cause of death):
OS [days] = date of death - date of randomisation +1
For patients known to be alive by the end of trial:
OS (censored) [days] = the last date when the patient was known to be alive - date of randomisation +1 OS was to be analysed similarly to DFS.
- Health Related Quality of Life (HRQOL) [ Time Frame: up to 4 years ]
The main analysis of HRQOL questionnaires was to focus on the change in score from baseline in the following scales measured on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and EORTC QLQ-H&N35:
- Global Health Status/ Quality of Life (QOL) Scale
- Pain Scale
- Swallowing Scale
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): NCT02131155
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|