The efficacy of postoperative bio-chemoradiotherapy using cetuximab and docetaxel for cis-platinum intolerant high-risk head and neck cancer patients.
Conditions
Interventions
Radiotherapy is delivered in conventional fractions of 1.8 Gy to a total dose of 66.6 Gy, 5 days per week, using 4-6 MV X-rays. The radiation fields are set up as the primary tumor and, prophylactical
subsequent weeks: 250 mg/m2) and DTX (25mg/m2).
Sponsors
Yokohama City University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Prior to enrollment in this trial, the patients must meet all of the following criteria: pathologically proven carcinoma; primary tumor located in the nasal/paranasal sinus, oral cavity, larynx, oropharynx and hypopharynx; clinically advanced stage (stage III or IV) on visual and endoscopic examinations and imaging examinations; e.g., CT, magnetic resonance imaging (MRI), ultrasonic echo (US) and/or PET-CT; primary site assessed as resectable by definitive surgery and regional lymph node by neck dissection on CT, MRI and/or US; no distant metastasis on PET-CT (cM0); aged over 20 years old (regarded as legally adult in Japan); PS 0-2 on ECOG criteria; sufficient general condition for the operation under general anesthesia; CDDP intolerant; e.g., advanced age (over 75-year-old), poor renal function (e-GFR < 60 ml/min/1.73m2), insufficient bone marrow function (white blood cell count < 3,000/mm3, neutrophil count < 1,500/mm3, platelet count < 7.5x104/mm3), hearing impairment, drug allergy, past history of CDDP use and/or poor general condition; and provision of written informed consent.
Exclusion criteria
Exclusion criteria: Prior to enrollment in this trial, the patients must not meet any of the following criteria: uncurable synchronous malignancies, priority systemic diseases, and refusal to undergo the definitive surgery and/or postoperative radiotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year disease free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year overall survival, 2-year recurrence free survival, and 2-year locoregional control survival | — |
Countries
Japan
Contacts
Public ContactGoshi Nishimura
Yokohama City University, School of Medicine Department of Otorhinolaryngology, Head and Neck Surgery
Outcome results
None listed