A Randomized Trial Evaluating a Very Intense Radiotherapy-Chemotherapy Regimen Versus a Very Accelerated Radiotherapy in Advanced Head and Neck Squamous Cell Carcinoma
Patients with a palpable N2b-c or N3 HNSCC strictly unresectable were randomized to receive
either accelerated RT-CT delivering to the primary tumor 62-64 Gy / 5 weeks in 31-32
fractions of 2 Gy BID or very accelerated RT delivering 62-64 Gy in 31-32 fractions of 2 Gy
BID and 22-23 days. In the accelerated RT-CT arm, 3 cycles of CDDP 100 mg/m2 were delivered
at day 1, 16, 32 and 2 cycles of 5 Fu 1000 mg/m2 day 1 to 5 and 31 to 35. One month after
completion of the concomitant RT-CT, 2 additional cycles of CDDP-5FU were given in patients
responding (> 50%) to the initial course of RT-CT. The end points were event free survival
and survival.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Event free survival (event = progressive disease or relapse or or death from any cause)
Jean Bourhis
Principal Investigator
Gustave Roussy, Cancer Campus, Grand Paris
France: Ministry of Health
VADN3
NCT00162708
July 1996
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