Head and Neck Neoplasms Clinical Trial
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
| Verified date | November 2017 |
| Source | Boehringer Ingelheim |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 617 |
| Est. completion date | September 12, 2016 |
| Est. primary completion date | September 12, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion criteria: 1. Histologically or cytologically confirmed loco-regionally advanced head and neck squamous cell carcinoma (HNSCC), stage III to IVb 2. Unresected tumour prior to chemo-radiotherapy (CRT) 3. Concomitant CRT completed prior to randomisation 4. After concomitant platinum-based CRT, no evidence of disease (NED) on clinical and radiographic examinations 5. Eastern cooperative oncology group (ECOG) performance status 0 or 1 Exclusion criteria: 1. Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules, EGFR-targeted antibodies, and/or any investigational agents for HNSCC 2. Patients with smoking history of less than or equal to 10 pack years and with primary tumour site of base of tongue and/or tonsil 3. Any other malignancy (except for simultaneous HNSCC primaries, appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ) unless free of disease for at least five years 4. Known pre-existing Interstitial Lung Disease (ILD) 5. Pregnancy or breast feeding |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | 1200.131.05451 Boehringer Ingelheim Investigational Site | Ciudad Autonoma de Bs As | |
| Argentina | 1200.131.05457 Boehringer Ingelheim Investigational Site | Cordoba | |
| Argentina | 1200.131.05458 Boehringer Ingelheim Investigational Site | San Miguel de Tucuman | |
| Argentina | 1200.131.05452 Boehringer Ingelheim Investigational Site | Santa Fe | |
| Argentina | 1200.131.05453 Boehringer Ingelheim Investigational Site | Villa Dominico | |
| Australia | 1200.131.06151 Boehringer Ingelheim Investigational Site | Wooloongabba | Queensland |
| Austria | 1200.131.04353 Boehringer Ingelheim Investigational Site | Leoben | |
| Austria | 1200.131.04357 Boehringer Ingelheim Investigational Site | Linz | |
| Austria | 1200.131.04355 Boehringer Ingelheim Investigational Site | Salzburg | |
| Austria | 1200.131.04351 Boehringer Ingelheim Investigational Site | Wien | |
| Austria | 1200.131.04359 Boehringer Ingelheim Investigational Site | Wien | |
| Belgium | 1200.131.03259 Boehringer Ingelheim Investigational Site | Brussel | |
| Belgium | 1200.131.03256 Boehringer Ingelheim Investigational Site | Charleroi | |
| Belgium | 1200.131.03255 Boehringer Ingelheim Investigational Site | Hasselt | |
| Belgium | 1200.131.03253 Boehringer Ingelheim Investigational Site | Kortrijk | |
| Belgium | 1200.131.03252 Boehringer Ingelheim Investigational Site | Liège | |
| Belgium | 1200.131.03254 Boehringer Ingelheim Investigational Site | Liège | |
| Belgium | 1200.131.03258 Boehringer Ingelheim Investigational Site | Namur | |
| Brazil | 1200.131.05554 Boehringer Ingelheim Investigational Site | Barretos | |
| Brazil | 1200.131.05555 Boehringer Ingelheim Investigational Site | Jau | |
| Brazil | 1200.131.05557 Boehringer Ingelheim Investigational Site | Passo Fundo | |
| Brazil | 1200.131.05553 Boehringer Ingelheim Investigational Site | Porto Alegre | |
| Brazil | 1200.131.05551 Boehringer Ingelheim Investigational Site | Sao Paulo | |
| Brazil | 1200.131.05556 Boehringer Ingelheim Investigational Site | Sao Paulo | |
| Canada | 1200.131.00153 Boehringer Ingelheim Investigational Site | Montreal | Quebec |
| Canada | 1200.131.00154 Boehringer Ingelheim Investigational Site | Montreal | Quebec |
| Canada | 1200.131.00155 Boehringer Ingelheim Investigational Site | Montreal | Quebec |
| Canada | 1200.131.00157 Boehringer Ingelheim Investigational Site | Toronto | Ontario |
| Canada | 1200.131.00152 Boehringer Ingelheim Investigational Site | Vancouver | British Columbia |
| Canada | 1200.131.00151 Boehringer Ingelheim Investigational Site | Windsor | Ontario |
| Chile | 1200.131.05652 Boehringer Ingelheim Investigational Site | Vina De Mar | |
| Chile | 1200.131.05651 Boehringer Ingelheim Investigational Site | Vina del Mar | |
| Czechia | 1200.131.04254 Boehringer Ingelheim Investigational Site | Brno | |
| Czechia | 1200.131.04253 Boehringer Ingelheim Investigational Site | Praha 5 | |
| Czechia | 1200.131.04251 Boehringer Ingelheim Investigational Site | Praha 8 | |
| Denmark | 1200.131.04551 Boehringer Ingelheim Investigational Site | København Ø | |
| Egypt | 1200.131.2052 Boehringer Ingelheim Investigational Site | Alexandria | |
| Finland | 1200.131.35851 Boehringer Ingelheim Investigational Site | Turku | |
| France | 1200.131.03353 Boehringer Ingelheim Investigational Site | Le Havre | |
| France | 1200.131.03362 Boehringer Ingelheim Investigational Site | Marseille Cedex 5 | |
| France | 1200.131.03359 Boehringer Ingelheim Investigational Site | Nice cedex 2 | |
| France | 1200.131.03365 Boehringer Ingelheim Investigational Site | Orléans Cedex 2 | |
| France | 1200.131.03355 Boehringer Ingelheim Investigational Site | Pierre-Bénite | |
| France | 1200.131.03367 Boehringer Ingelheim Investigational Site | Rouen | |
| France | 1200.131.03370 Boehringer Ingelheim Investigational Site | Saint Cloud | |
| France | 1200.131.03354 Boehringer Ingelheim Investigational Site | Saint Herblain Cedex | |
| France | 1200.131.03369 Boehringer Ingelheim Investigational Site | Saint Priest en Jarez | |
| France | 1200.131.03366 Boehringer Ingelheim Investigational Site | Salouel | |
| France | 1200.131.03356 Boehringer Ingelheim Investigational Site | Tours | |
| France | 1200.131.03357 Boehringer Ingelheim Investigational Site | Villejuif Cedex | |
| Germany | 1200.131.04954 Boehringer Ingelheim Investigational Site | Essen | |
| Germany | 1200.131.04961 Boehringer Ingelheim Investigational Site | Freiburg | |
| Germany | 1200.131.04953 Boehringer Ingelheim Investigational Site | Hannover | |
| Germany | 1200.131.04956 Boehringer Ingelheim Investigational Site | Jena | |
| Germany | 1200.131.04959 Boehringer Ingelheim Investigational Site | Kaiserslautern | |
| Germany | 1200.131.04951 Boehringer Ingelheim Investigational Site | Leipzig | |
| Germany | 1200.131.04957 Boehringer Ingelheim Investigational Site | Rostock | |
| Germany | 1200.131.04964 Boehringer Ingelheim Investigational Site | Trier | |
| Germany | 1200.131.04963 Boehringer Ingelheim Investigational Site | Ulm | |
| Germany | 1200.131.04962 Boehringer Ingelheim Investigational Site | Villingen-Schwenningen | |
| Greece | 1200.131.03054 Boehringer Ingelheim Investigational Site | Chaidari | |
| Greece | 1200.131.03052 Boehringer Ingelheim Investigational Site | Thessaloniki | |
| Hungary | 1200.131.03651 Boehringer Ingelheim Investigational Site | Budapest | |
| Hungary | 1200.131.03652 Boehringer Ingelheim Investigational Site | Budapest | |
| Hungary | 1200.131.03656 Boehringer Ingelheim Investigational Site | Budpest | |
| Hungary | 1200.131.03654 Boehringer Ingelheim Investigational Site | Debrecen | |
| Hungary | 1200.131.03655 Boehringer Ingelheim Investigational Site | Kecskemet | |
| India | 1200.131.09178 Boehringer Ingelheim Investigational Site | Ahmadabad | |
| India | 1200.131.09165 Boehringer Ingelheim Investigational Site | Bangalore | |
| India | 1200.131.09152 Boehringer Ingelheim Investigational Site | Bikaner | |
| India | 1200.131.09163 Boehringer Ingelheim Investigational Site | Chennai | |
| India | 1200.131.09173 Boehringer Ingelheim Investigational Site | Chennai | |
| India | 1200.131.09179 Boehringer Ingelheim Investigational Site | Delhi | |
| India | 1200.131.09170 Boehringer Ingelheim Investigational Site | Gurgaon | |
| India | 1200.131.09180 Boehringer Ingelheim Investigational Site | Hyderabad | |
| India | 1200.131.09172 Boehringer Ingelheim Investigational Site | Jaipur | |
| India | 1200.131.09176 Boehringer Ingelheim Investigational Site | Karamsad,Anand, Gujarat | |
| India | 1200.131.09162 Boehringer Ingelheim Investigational Site | Madurai, Tamil Nadu | |
| India | 1200.131.09175 Boehringer Ingelheim Investigational Site | Mazagaon, Mumbai | |
| India | 1200.131.09151 Boehringer Ingelheim Investigational Site | New Delhi | |
| India | 1200.131.09164 Boehringer Ingelheim Investigational Site | Pune | |
| India | 1200.131.09159 Boehringer Ingelheim Investigational Site | Vishakapatnam | |
| Israel | 1200.131.97251 Boehringer Ingelheim Investigational Site | Haifa | |
| Israel | 1200.131.97253 Boehringer Ingelheim Investigational Site | Petach Tikva | |
| Italy | 1200.131.03957 Boehringer Ingelheim Investigational Site | Confreria (CN) | |
| Italy | 1200.131.03951 Boehringer Ingelheim Investigational Site | Milano | |
| Italy | 1200.131.03955 Boehringer Ingelheim Investigational Site | Milano | |
| Italy | 1200.131.03960 Boehringer Ingelheim Investigational Site | Milano | |
| Japan | 1200.131.08156 Boehringer Ingelheim Investigational Site | Aichi, Nagoya | |
| Japan | 1200.131.08153 Boehringer Ingelheim Investigational Site | Chiba, Kashiwa | |
| Japan | 1200.131.08151 Boehringer Ingelheim Investigational Site | Hokkaido, Sapporo | |
| Japan | 1200.131.08161 Boehringer Ingelheim Investigational Site | Hyogo, Akashi | |
| Japan | 1200.131.08157 Boehringer Ingelheim Investigational Site | Hyogo, Kobe | |
| Japan | 1200.131.08159 Boehringer Ingelheim Investigational Site | Kanagawa, Isehara | |
| Japan | 1200.131.08164 Boehringer Ingelheim Investigational Site | Miyagi, Natori | |
| Japan | 1200.131.08160 Boehringer Ingelheim Investigational Site | Osaka, Osaka | |
| Japan | 1200.131.08155 Boehringer Ingelheim Investigational Site | Shizuoka, Sunto-gun | |
| Japan | 1200.131.08152 Boehringer Ingelheim Investigational Site | Tochigi, Shimotsuke | |
| Japan | 1200.131.08163 Boehringer Ingelheim Investigational Site | Tokyo, Koto-ku | |
| Japan | 1200.131.08154 Boehringer Ingelheim Investigational Site | Tokyo, Meguro-ku | |
| Mexico | 1200.131.05252 Boehringer Ingelheim Investigational Site | Mexico | |
| Netherlands | 1200.131.03152 Boehringer Ingelheim Investigational Site | Amsterdam | |
| Netherlands | 1200.131.03153 Boehringer Ingelheim Investigational Site | Leiden | |
| Netherlands | 1200.131.03151 Boehringer Ingelheim Investigational Site | Rotterdam | |
| Portugal | 1200.131.35155 Boehringer Ingelheim Investigational Site | Almada | |
| Portugal | 1200.131.35154 Boehringer Ingelheim Investigational Site | Coimbra | |
| Portugal | 1200.131.35152 Boehringer Ingelheim Investigational Site | Évora | |
| Portugal | 1200.131.35153 Boehringer Ingelheim Investigational Site | Lisboa | |
| Portugal | 1200.131.35151 Boehringer Ingelheim Investigational Site | Porto | |
| Russian Federation | 1200.131.00759 Boehringer Ingelheim Investigational Site | Moscow | |
| Russian Federation | 1200.131.00753 Boehringer Ingelheim Investigational Site | Omsk | |
| Russian Federation | 1200.131.00760 Boehringer Ingelheim Investigational Site | Pyatigorsk | |
| Russian Federation | 1200.131.00761 Boehringer Ingelheim Investigational Site | Pyatigorsk | |
| Russian Federation | 1200.131.00763 Boehringer Ingelheim Investigational Site | St. Petersburg | |
| Russian Federation | 1200.131.00755 Boehringer Ingelheim Investigational Site | Ufa | |
| Russian Federation | 1200.131.00762 Boehringer Ingelheim Investigational Site | Ufa | |
| Spain | 1200.131.03461 Boehringer Ingelheim Investigational Site | Ávila | |
| Spain | 1200.131.03451 Boehringer Ingelheim Investigational Site | Barcelona | |
| Spain | 1200.131.03454 Boehringer Ingelheim Investigational Site | Barcelona | |
| Spain | 1200.131.03463 Boehringer Ingelheim Investigational Site | Girona | |
| Spain | 1200.131.03452 Boehringer Ingelheim Investigational Site | Hospitalet de Llobregat | |
| Spain | 1200.131.03459 Boehringer Ingelheim Investigational Site | Lugo | |
| Spain | 1200.131.03457 Boehringer Ingelheim Investigational Site | Madrid | |
| Spain | 1200.131.03464 Boehringer Ingelheim Investigational Site | Madrid | |
| Spain | 1200.131.03465 Boehringer Ingelheim Investigational Site | Madrid | |
| Spain | 1200.131.03456 Boehringer Ingelheim Investigational Site | Málaga | |
| Spain | 1200.131.03462 Boehringer Ingelheim Investigational Site | Málaga | |
| Spain | 1200.131.03455 Boehringer Ingelheim Investigational Site | Pamplona | |
| Spain | 1200.131.03460 Boehringer Ingelheim Investigational Site | Pozuelo De Alarcón, Madrid | |
| Spain | 1200.131.03466 Boehringer Ingelheim Investigational Site | Sevilla | |
| Spain | 1200.131.03458 Boehringer Ingelheim Investigational Site | Zaragoza | |
| Sweden | 1200.131.04652 Boehringer Ingelheim Investigational Site | Göteborg | |
| Sweden | 1200.131.04651 Boehringer Ingelheim Investigational Site | Stockholm | |
| Switzerland | 1200.131.04151 Boehringer Ingelheim Investigational Site | Basel | |
| Switzerland | 1200.131.04152 Boehringer Ingelheim Investigational Site | Bern | |
| Ukraine | 1200.131.03854 Boehringer Ingelheim Investigational Site | Kharkiv | |
| Ukraine | 1200.131.03851 Boehringer Ingelheim Investigational Site | Kiev | |
| United Kingdom | 1200.131.04456 Boehringer Ingelheim Investigational Site | Denbighshire | |
| United Kingdom | 1200.131.04455 Boehringer Ingelheim Investigational Site | Edinburgh | |
| United Kingdom | 1200.131.04459 Boehringer Ingelheim Investigational Site | Exeter | |
| United Kingdom | 1200.131.04460 Boehringer Ingelheim Investigational Site | Glasgow | |
| United Kingdom | 1200.131.04453 Boehringer Ingelheim Investigational Site | Leicester | |
| United Kingdom | 1200.131.04451 Boehringer Ingelheim Investigational Site | London | |
| United Kingdom | 1200.131.04452 Boehringer Ingelheim Investigational Site | Manchester | |
| United Kingdom | 1200.131.04454 Boehringer Ingelheim Investigational Site | Sheffield | |
| United Kingdom | 1200.131.04458 Boehringer Ingelheim Investigational Site | Sutton | |
| United Kingdom | 1200.131.04457 Boehringer Ingelheim Investigational Site | Whitchurch, Cardiff | |
| United States | 1200.131.00177 Boehringer Ingelheim Investigational Site | Aurora | Colorado |
| United States | 1200.131.00173 Boehringer Ingelheim Investigational Site | Baltimore | Maryland |
| United States | 1200.131.00176 Boehringer Ingelheim Investigational Site | Boston | Massachusetts |
| United States | 1200.131.00175 Boehringer Ingelheim Investigational Site | Lebanon | New Hampshire |
| United States | 1200.131.00171 Boehringer Ingelheim Investigational Site | Little Rock | Arkansas |
| United States | 1200.131.00185 Boehringer Ingelheim Investigational Site | New Haven | Connecticut |
| United States | 1200.131.00182 Boehringer Ingelheim Investigational Site | Omaha | Nebraska |
| United States | 1200.131.00181 Boehringer Ingelheim Investigational Site | Orange | California |
| United States | 1200.131.00172 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania |
| United States | 1200.131.00184 Boehringer Ingelheim Investigational Site | San Antonio | Texas |
| United States | 1200.131.00198 Boehringer Ingelheim Investigational Site | Spokane Valley | Washington |
| 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 | 1200.131.00183 Boehringer Ingelheim Investigational Site | Wenatchee | Washington |
| United States | 1200.131.10200 Boehringer Ingelheim Investigational Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, Portugal, Russian Federation, Spain, Sweden, Switzerland, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Disease Free Survival (DFS) | 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. | Up to 5 years | |
| Secondary | Disease Free Survival (DFS) Rate at 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. | Up to 2 years | |
| Secondary | Percentage of Patient Deaths (Overall Survival (OS)) | 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. | Up to 5 years | |
| Secondary | Patients With Improved Health Related Quality of Life (HRQOL) | 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. | Up to 5 years | |
| Secondary | Time to Deterioration in Health Related Quality of Life (HRQOL) | 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. | Up to 5 years | |
| Secondary | Health Related Quality of Life (HRQOL) Scores Over Time | 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. | Baseline and 5 years |
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|---|---|---|---|
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