At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 134 enrolled
Drug / intervention
AFATINIB +1 moredrug
Likely dose
AFATINIB 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled Phase III Study, to Evaluate the Efficacy of Afatinib (BIBW2992) in Maintenance Therapy After Post- Operative Radio-chemotherapy in Squamous-cell Carcinoma of the Head and Neck: GORTEC 2010-02
In Brief
A Phase 3 clinical trial evaluating AFATINIB and Placebo of AFATINIB for Head and Neck Squamous Cell Carcinoma. Completed, enrolled 134 participants across 26 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of Afatinib in maintenance therapy after post-operative radiochemotherapy (66 Gy and Cisplatin at the dose of 100mg/m2 every 3 weeks)in squamous cell carcinoma of the head and neck.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Squamous Cell Carcinoma
CountriesFrance
CollaboratorsBoehringer Ingelheim
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 2011
Enrollment StartSep 2011
Primary CompletionNov 2020
Study CompletionMay 2021
TodayJul 2026
First PostedSep 1, 2011
Enrollment StartSep 1, 2011
Primary CompletionNov 1, 2020
Study CompletionMay 1, 2021
TodayJul 2, 2026
Enrollment to primary: 9.2 yearsPosted 14.8 years ago
Interventions
AFATINIBdrug
AFATINIBat the dose of 40 mg/during the 1st month and then 50 mg/d during the 11 following months
Placebo of AFATINIBdrug
placebo of Afatinib at the dose of 40 mg/during the 1st month and then 50 mg/d during the 11 following months