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Afatinib as Adjuvant Therapy in High-Risk HNSCC
NCT01824823Phase 2
Key facts
- Status
- Terminated
- Start
- Jun 2014
- Primary completion
- Dec 2015
- Countries
- 1
- Sponsor
- ECOG-ACRIN Cancer Research Group
- Modality
- Small Molecules
- Drugs
- afatinib
- Conditions
- head and neck squamous cell carcinoma (HNSCC)
01
Overview
Phase 2, randomised, double-blind trial in head and neck squamous cell carcinoma (HNSCC) comparing Afatinib with Placebo (2 arms). Primary endpoint: Disease-free Survival at 5 years. Started Jun 2014; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Afatinib
Afatinib PO QD days 1-28
Placebo
Placebo PO QD days 1-28
03
Who it enrols
Patients with stage III-IV HNSCC who have completed chemoradiation and neck dissection with viable tumor cells in lymph nodes, ECOG 0-1, and adequate organ function.
04
Endpoints
Primary
Disease-free Survival
Secondary
Recurrence Rate
Overall Survival
Toxicity
Circulating DNA
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