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.
This study is being sponsored by a cooperative medical group.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
94
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
Rescue surgery
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital de Manresa
Specific survival free of total laryngectomy
Time from the start of TPF treatment to death caused by the disease or by the treatment of the disease, or even to surgery involving total laryngectomy. Deaths caused by other reasons were considered "censored" data on the date of death.
Time frame: Three years after the end of treatment with radiotherapy and cetuximab
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Manresa, Barcelona, Spain
Hospital Clínic i Provincial de Barcelona
Barcelona, Spain
Hospital San Pedro de Alcántara
Cáceres, Spain
Hospital Dr.Josep Trueta (ICO Girona)
Girona, Spain
Hospital Universitario Virgen de las Nieves
Granada, Spain
Oncogranada
Granada, Spain
Hospital Xeral Calde
Lugo, Spain
Hospital Gregorio Marañon
Madrid, Spain
...and 7 more locations