PHASE I/II TRIAL OF ERLOTINIB, RADIATIONTHERAPY, AND CISPLATIN IN PATIENTS WITH COMPLETE RESECTED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECKEnsayo Fase I/II de Erlotinib en combinación con radioterapia y cisplatino en pacientes con carcinoma epidermoide de cabeza y cuello localmente avanzado resecado quirúrgicamente

Group of Clinical Investigation in Radiotherapy Oncology (GICOR)0 sites90 target enrollmentSeptember 13, 2005

Overview

No summary available.

Registry

who.int

Start Date

September 13, 2005

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Group of Clinical Investigation in Radiotherapy Oncology (GICOR)

•1\. \- Patients with histological proof of epidermoid carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx, treated with surgical resection with curative intent.
•2\. \- Surgical resection must have taken place within 8 weeks prior to the patient’s inclusion in the study.
•3\. \- In those patients having clinical regional lymph node involvement radical neck dissection is mandatory. However, radical neck dissection is not an inclusion criterion in patients staged as N0\.
•4\. \- Age 18\-70 years.
•5\. \- Anticipated life expectancy of \= 12 weeks.
•6\. \- Patients should have at least one of the following criteria:
•?Pathological T3\-4 tumor stage, apart from T3N0 of the larynx with negative margins
•?Pathological N2\-3 nodal stage.
•?Unfavorable pathological findings such as extranodal spread, positive resection margins, perineural and/or vascular involvement.
•7\. \- Written informed consent given by the patient.

•1\. \- Histology other than squamous cell carcinoma.
•2\. \- Presence of macroscopic residual disease.
•3\. \- Previous treatment with chemotherapy or radiotherapy or EGFR\-targeted agents.
•4\. \- Incomplete resection of the primary tumor or incomplete neck dissection.
•5\. \- Patients being diagnosed with any other malignant disease, excluding resected nonmelanoma skin cancer or resected uterine cervix carcinoma.
•6\. \- Pregnant or nursing women.
•7\. \- Active infection.
•8\. \- Concomitant severe illness (according to the opinion of the investigator) or whose estimated survival for this concomitant pathology is lower than that estimated for the neoplasm disease.
•9\. \- Uncontrolled psychiatric illness.
•10\. \- Inability to take oral medication, requiring intravenous feeding or prior surgical procedures affecting absorption or having active peptic ulcer.