A randomised clinical trial to contrast radiotherapy with radiotherapy and methotrexate given synchronously in head and neck cancer.

Three hundred and thirteen patients with squamous cell cancer of the head and neck were entered in a randomised clinical trial to determine whether the addition of methotrexate during the course of irradiation improved the rate of primary control and subsequent survival. The overall primary control (P = 0.016) and survival (P = 0.075) for the patients receiving methotrexate was better than the patients treated by radiotherapy alone. The improvement in primary control (P = 0.0019) and survival (P = 0.0089) in patients with oropharyngeal cancers who had methotrexate in addition to radiotherapy is statistically significant. The treatment was well tolerated and there has been no increase of late morbidity.

RCT Entities:   Population Interventions Outcomes