A Randomised Study of TPF as Neoadjuvant Chemotherapy Followed by Concomitant Chemoradiotherapy (CRT) With Conventional Radiotherapy (RT) Versus Concomitant CRT With Accelerated RT in Patients With Locally Advanced Head and Neck Squamous Cell Cancer (HNSCC) in Good Condition. The Condor Study. A Study of the Dutch Head and Neck Cancer Group (DHNCG).
Induction Chemotherapy TPF(arm A and B)
: Docetaxel 75 mg/m2 iv on day 1, Cisplatin 75 mg/ m2 iv on day 1, 5-FU 750 mg/ m2/day iv
continuous infusion (in Hickman or port a cath) on days 1-5; prophylactic G-CSF
This cycle will be repeated every 21 days for a maximum of 4 cycles. Clinical evaluation
after each cycle and radiological evaluation after 2 cycles will take place. In case of PD
or SD (after 2 cycles) with no minor response (no decrease in measurable disease from
baseline) concomitant chemoradiotherapy will started per protocol.
Surgery The investigators in each centre can decide neck surgery for residual tumor
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
feasibility of both study-arms
C.M.L. van Herpen, MD, Phd
UMCN st Radboud
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)