Open Label Randomized, Multi-centre Phase III Trial of TPF Plus Concomitant Treatment With Cisplatin and Radiotherapy Versus Concomitant Cetuximab and Radiotherapy in Locally Advanced, Unresectable Head and Neck Cancer.

NCT00716391 Phase 3 COMPLETED

An Open Label Randomized, Multi-Centre Phase III Trial of TPF Chemotherapy Plus Concomitant Treatment With Cisplatin and Conventional Radiotherapy Versus TPF Chemotherapy Plus Concomitant Cetuximab and Conventional Radiotherapy in Locally Advanced, Unresectable Head and Neck Cancer.

Details

Lead sponsor	Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
Phase	Phase 3
Status	COMPLETED
Enrolment	519
Start date	2008-07-07
Completion	2017-12

Conditions

• Head and Neck Cancer

Interventions

• TPF, radiotherapy and cisplatin.
• TPF, radiotherapy and cetuximab.

Primary outcomes

• Global survival — Up to 89 months
  The time from the start of induction chemotherapy with TPF to death due to any cause or to the last check-up in the case of living patients

Countries

Spain