Cetuximab Plus Radiotherapy Versus Cisplatin Plus Radiotherapy in Locally Advanced Head and Neck Cancer
Status:
Terminated
Trial end date:
2015-05-20
Target enrollment:
Participant gender:
Summary
BACKGROUND:
Concomitant radiotherapy and cisplatin (CDDP) based chemotherapy is the standard treatment
for LA-NHSCC. This combined modality treatment is linked with considerable acute local and
systemic toxicity.EGFR is overexpressed in 90-100% of the HNSCC cases and is considered an
unfavourable prognostic marker. EGFR costitutive activation is linked with HNSCC
pathogenesis.
Cetuximab is a monoclonal anti-EGFR antibody blocking the activation of the receptor and
signal transduction. Cetuximab combined with radiotherapy is superior to radiotherapy only in
the treatment of LA-HNSCC and is characterized by an acceptable toxicity profile.
RATIONALE:
A direct comparison between concomitant chemoradiotherapy with Cisplatin and the concomitant
treatment with radiotherapy associated to cetuximab does not exist.
STUDY DESIGN:
Arm A: Radical radiotherapy (doses and volumes) concomitant with chemotherapy with Cisplatin
(40 mg/mq/week) Arm B: Radical radiotherapy (doses and volumes) concomitant with therapy with
the monoclonal antibody Cetuximab (400 mg/m2 ["loading dose"] and subsequently 250 mg
/m2/week)