LUX-Head&Neck 3: Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy
- Conditions
- Head and Neck Neoplasms
- Interventions
- Registration Number
- NCT01856478
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This randomized, open-label, phase III study will be performed in patients with recurrent and/or metastatic head and neck cancer which has progressed after platinum-based therapy. The objectives of this trial are to compare the efficacy and safety of afatinib versus methotrexate.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 340
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description afatinib afatinib oral intake, once daily methotrexate methotrexate intravenous bolus injection, once weekly
- Primary Outcome Measures
Name Time Method progression free survival (PFS), defined as the time from the date of randomization to the date of progression evaluated according to RECIST 1.1 or to the date of death, whichever occurs first up to 2 years
- Secondary Outcome Measures
Name Time Method Overall survival (OS), defined as the time from the date of randomization to the date of death (regardless of the cause of death) up to 3 years Objective response defined as complete response (CR) or partial response (PR) determined by RECIST 1.1 according to the best response to study medication up to 2 years Health related quality of life (HRQOL) will be assessed based on patient-reported questionaires up to 2 years
Trial Locations
- Locations (52)
Harbin Medical University Cancer Hospital
🇨🇳Harbin, China
Beijing Chao-Yang Hospital
🇨🇳Beijing, China
Cancer Hospital of Chinese Academy of Medical Science
🇨🇳Beijing, China
Navy General Hospital
🇨🇳Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, China
The First Affiliated Hospital Of Bengbu Medical College
🇨🇳Bengbu, China
The First Hospital of Jilin University
🇨🇳Changchun, China
Sichuan Cancer Hospital
🇨🇳Chengdu, China
West China Hospital
🇨🇳Chengdu, China
Sun Yat-Sen University Cancer Center
🇨🇳Guangzhou, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, China
the 81th Hospital of PLA
🇨🇳Nanjing, China
Renji Hospital Shanghai Jiaotong Univesrity School of Medicine
🇨🇳Shanghai, China
Shanghai Changzheng Hospital
🇨🇳Shanghai, China
Shanghai Ninth People's Hospital
🇨🇳Shanghai, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, China
Wuhan Union Hospital
🇨🇳Wuhan, China
Tongji Hospital, Tongji University
🇨🇳Wuhan, China
Alexandria Clinical Research Center
🇪🇬Alexandria, Egypt
National Cancer Institute, Cairo University
🇪🇬Cairo, Egypt
Mansoura University Faculty of Medicine
🇪🇬Dakahlia, Egypt
Pamela Youde Nethersole Eastern Hospital
🇭🇰Hong Kong, Hong Kong
Queen Mary Hospital
🇭🇰Hongkong, Hong Kong
Prince of Wales Hospital
🇭🇰Shatin, Hong Kong
Sujan Surgical Cancer Hospital
🇮🇳Amravati, India
Pristine Hospital
🇮🇳Bengaluru, India
Acharya Tulsi Regional Cancer Treatment & Research Institute
🇮🇳Bikaner, India
Rajiv Gandhi Government General Hospital
🇮🇳Chennai, India
M N J Institute of Oncology and Regional Cancer Centre
🇮🇳Hyderabad, India
Geetanjali Medical College and Hospital
🇮🇳Jaipur, India
J K Cancer Institute
🇮🇳Kanpur, India
B. P .Poddar Hospital & Medical Research Ltd.
🇮🇳Kolkata, West Bengal, India
King George Medical University
🇮🇳Lucknow, India
Government Medical College & Hospital
🇮🇳Nagpur, India
Shatabdi Hospital, Nashik
🇮🇳Nasik, India
Ruby Hall Clinic
🇮🇳Pune, India
Noble Hospital Pvt Ltd
🇮🇳Pune, India
National Cancer Center
🇰🇷Goyang, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St.Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Perpetual Succour Hospital (Cebu)
🇵🇭Cebu City, Philippines
St. Luke's Medical Center
🇵🇭Quezon City, Philippines
Keelung Chang Gung Memorial Lover's Lake Branch
🇨🇳Keelung City, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Tri-Service General Hospital
🇨🇳Taipei, Taiwan
Maharaj Nakom Chiangmai Hospital
🇹🇭Chiang Mai, Thailand
Srinagarind Hospital
🇹🇭Muang, Thailand
Naresuan University Hospital
🇹🇭Phitsanulok, Thailand
Songklanagarind Hospital
🇹🇭Songkla, Thailand