Unresectable Locally advanced Squamous Cell Carcinoma of the Head and Neck Head and neck cancer
Conditions
Interventions
Paclitaxel, Carboplatin and Cetuximab (PCE) followed by Cisplatin and Radiation
Sponsors
Tahara Makoto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically or cytological proven squamous cell carcinoma of the head and neck 2)Primary lesion located at the larynx, oropharynx or hypopharynx 3)Unresectable LASCCHN 4)No cancer fistula 5)Measurable disease 6)No evidence of distant metastasis. 7)ECOG PS 0 or 1 8)Age between 20 and 75 years 9)Adequate organ function 10)HBsAg negative 11)No abnormal finding on electrocardiogram 12)Women of child bearing potential and men who are able to father a child agree with using adequate contraception 13)Written informed consent to the study signed by the patient
Exclusion criteria
Exclusion criteria: 1) Primary lesion located at the nasopharynx, oral cavity, nasal cavity, parasinus or salivary gland 2) Prior RT, CT or endocrine therapy for the current or any other malignancy 3) Current other synchronous primary double cancers and metachronous double cancers unless free of disease for at least five years (excluding superficial cancer that will be cured by endoscopic mucosal resection) 4) Severe myelosuppression or infection 5) Pulmonary fibrosis, acute lung injury or Intestinal pneumonia 6) Clinically relevant comorbidity included heart failure, renal failure, liver failure, uncontrolled hypertension or uncontrolled diabetes mellitus 7) Active gastrointestinal bleeding 8) Cardiac or peritoneal effusion that needs medical attention 9) History of severe hypersensitivity 10) Known hypersensitivity against any components of the trial treatment including excipients 11) Pregnancy or breast feeding 12) Current administration of disulfiram, Cyanamide, Carmofur or procarbazine hydrochloride 13) Previous treatment with cetuximab or monoclonal antibody 14) Other significant disease that in the investigator's opinion would exclude the subject from the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of chemoradiation completion | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate Frequency and types of adverse events Time to local progression Time to distant metastasis Event free survival Overall survival | — |
Contacts
Public ContactTomohiro Enokida
National Cancer Center Hospital East
Outcome results
None listed