NCT00765011

TPF Plus Radiotherapy and Cetuximab to Avoid Total Laryngectomy in Patients With Larynx Cancer

A Phase II Trial With Radiotherapy Plus Cetuximab to Evaluate Specific Survival Free of Laryngectomy in Patients With Resectable and Locally Advanced Larynx Cancer, After Treatment With TPF

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 94 (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

A Phase II Trial With Radiotherapy Plus Cetuximab to Evaluate Specific Survival Free of Laryngectomy in Patients With Resectable and Locally Advanced Larynx Cancer, After Treatment With TPF Chemotherapy.

Detailed description

This study is being sponsored by a cooperative medical group.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	TPF, radiotherapy and cetuximab	3 cycles of: cisplatin: 75mg/m2, i.v., 1 hour, once daily docetaxel: 75 mg/m2, i.v., 1 hour, once daily 5-fluorouracilo: 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
PROCEDURE	H&N surgery	Rescue surgery

Timeline

• Start date: 2008-10-01
• Primary completion: 2014-02-01
• Completion: 2015-05-12
• First posted: 2008-10-02
• Last updated: 2019-04-11

Locations

17 sites across 1 country: Spain