Cisplatin and 5-fluorouracil by continuous infusion combination produces a high response rate in squamous-cell carcinoma of the head and neck (SCCHN). Carboplatin (CBDCA) is a cisplatin analogue with lower emetic potential and nephrotoxicity, although the myelosuppression potential is higher. Tegafur (ftorafur, FT) is an analogue of 5-fluorouracil. It is absorbed well in its oral form and has moderate gastrointestinal and hematologic toxicity. This clinical trial tested the association of CBDCA i.v. plus FT p.o. in patients with SCCHN who had not been previously treated. Twenty-one patients were evaluable for response; the overall response was 62% (33% complete response, 29% partial response). Toxicity was moderate in most of the patients, although there was a treatment-related death.