Larynx Preservation With Induction Chemotherapy (Cisplatin, 5FU, Docetaxel) Followed by Radiotherapy Combined With Either Cisplatin or Cetuximab in Laryngopharyngeal Squamous Cell Carcinoma - A Randomised Phase II Study
At ASCO 2004 there were 3 major presentations issuing an increasing in survival:
- the update of the MACH-NC meta-analysis showed that actually only concurrent
chemo-irradiation trials found a significantly improved survival (in particular the
addition of cisplatinum alone to radiotherapy)
- the addition of docetaxel to the cisplatinum-5FU regimen (TPF) when compared with
- the addition of cetuximab to irradiation
On this basis we decided to carry-out a randomized phase II for previously untreated
patients requiring a total laryngectomy:
All patients after a complete work-up including a CTscan will receive 3 cycles of TPF(T: 75
mg/m², P: 75 mg/m² and 5FU 750 mg/m²).
Patients with response over 50 % (endoscopy and CTscan) will be randomized to receive either
irradiation (70 Gy) and cisplatinum (100 mg/m² on D1, D22 and D43) or irradiation (70 Gy)
with cetuximab (loading dose of 400 mg followed by weekly 250 mg for a total of 8 cycles.
Patients with less than 50% decease in tumour volume after TPF, patients with residual or
recurrent disease after either RT-CDDP or RT-cetuximab will get salvage total laryngectomy.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
rate of laryngeal preservation
Centre Oscar Lambret
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)