5571 Background: Induction chemotherapy (ICT) with a fluoropyrimidine, platinum and taxane combination followed by radiation therapy or concurrent chemoradiation (CRT) has become a new standard of care in locoregionally advanced, unresectable head and neck squamous cell carcinoma (SCC). The use of the same combination of three-drug therapy in ICT and CRT has not been adequalely tested for organ preservation. Methods: In this phase II study, patients (pts) who had biopsy-proven stage III or IV SCC and no distant metastasis, PS 0 or 1, good organ function and no prior chemotherapy or radiation received two cycles of chemotherapy (CT) with i.v. docetaxel 70 mg/m2 on day 1 plus i.v. carboplatin AUC 5 on day 1 plus capecitabine 1g/m2 orally daily b.i.d every 28 days. Patients with disease progression or stable disease were excluded. Responding pts received two more cycles of the same CT concurrent with concomitant boost radiation therapy (72 Gy). Results: Twenty-five pts were enrolled: 15 oropharynx, 8 larynx and 2 hypopharynx. Stage distribution was: III (24%), IVA (72%) and IVB (4%). All pts completed the ICT and CRT, and 96% received the planned four cycles of CT. The response rate was 88% and only one patient had progression after 3 months of treatment completion. Grade 3/4 neutropenia occurred in 20% and 56% of pts during ICT and CRT, respectively. During CRT, the rate of grade 3 febrile neutropenia was 36% and grade 3/4 mucositis was 72%. One patient died during treatment as a result of a ruptured aortic aneurysm. After a median follow-up of 4.6 years only one patient died as a result of metastatic disease. The median survival had not been reached. Neither tracheotomy, nor feeding tubes, were needed 6 months after finishing CRT. Conclusions: Three-drug induction therapy with docetaxel, carboplatin and capecitabine 1g/m2 followed by concurrent by the same agents and concomitant boost radiation therapy is feasible and very promising in a selected head and neck patient population, with high response and organ preservation rates. No significant financial relationships to disclose.