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TREMPLIN: Larynx Preservation Strategy
NCT00169247Phase 2
Key facts
- Status
- Completed
- Start
- Oct 2005
- Primary completion
- Apr 2011
- Countries
- 1
- Sponsor
- GORTEC
- Modality
- Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies
- Drugs
- cetuximab
- Conditions
- laryngeal squamous cell carcinoma (LSCC)hypopharyngeal squamous cell carcinoma (HSCC)
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Overview
Phase 2, randomised, open-label trial of cetuximab in laryngeal squamous cell carcinoma (LSCC) and hypopharyngeal squamous cell carcinoma (HSCC) (2 arms), sponsored by GORTEC. Primary endpoint: Rate of Laryngeal Preservation. Started Oct 2005; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
RT + Cisplatin
Radiotherapy 70 Gy + Cisplatin 100 mg/m2 D1, D22, D43
RT + Cetuximab
Radiotherapy 70 Gy + Cetuximab (400 mg loading, 250 mg weekly)
03
Who it enrols
Patients with locally advanced larynx or hypopharynx squamous cell carcinoma eligible for total laryngectomy, with good performance status and organ function, and no prior chemo/radiotherapy.
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Endpoints
Primary
Rate of Laryngeal Preservation
Secondary
Quality of Life
Laryngo-Esophageal Dysfunction-Free Survival
Overall Survival
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