NCT00716391

TPF Plus Cisplatin and Radiotherapy vs TPF Plus Cetuximab and Radiotherapy to Treat Head and Neck Cancer.

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 519 (actual)
• Sponsor: Grupo Español de Tratamiento de Tumores de Cabeza y Cuello · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study is being sponsored by a cooperative medical group.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
OTHER	TPF, radiotherapy and cisplatin.	3 cycles of: cisplatin: 75 mg/m2, i.v., 1 hour, once daily docetaxel: 75 mg/m2, i.v., 1 hour, once daily 5-fluorouracil: 750 mg/m2, i.v., 24 hours, 5 days Radiotherapy: 70Gy, divided into daily doses of 2 Gray (total days: 35) Cisplatin: 100 mg/m2, i.v., 1 hour, 3 days
OTHER	TPF, radiotherapy and cetuximab.	3 cycles of: cisplatin: 75 mg/m2, i.v., 1 hour, once daily docetaxel: 75 mg/m2, i.v., 1 hour, once daily 5-fluorouracil: 750 mg/m2, i.v., 24 hours, 5 days Radiotherapy: 70Gy, divided into daily doses of 2 Gray (total days: 35) Cetuximab: 400 mg/m2, i.v, 2 hours, 1 day Cetuximab: 250 mg/m2, i.v, 1 hour, 7 days

Timeline

• Start date: 2008-07-07
• Primary completion: 2017-07-18
• Completion: 2017-12-01
• First posted: 2008-07-16
• Last updated: 2019-05-24

Locations

39 sites across 1 country: Spain