Development of surgical quality-control mechanisms in large-scale prospective trials: head and neck intergroup report

One of the current national prospective clinical trials of the Head and Neck Intergroup explores the usage of chemotherapy in advanced operable head and neck cancer patients. The experimental arm consists of the addition of 3 courses of cisplatin-containing chemotherapy to standard treatment defined as surgery followed by postoperative radiotherapy. In the design of the study it is necessary to define not only the extent of the surgery performed for each eligible lesion, but also to insure uniformity of surgery performed between surgeons and institutions. This will hopefully insure that any variation between the 2 arms of the study represent the effect of the chemotherapy. The procedure to obtain and confirm uniformity of surgery is multifaceted. It is, however, fundamentally based upon the current TNM staging system and therefore has intrinsic limitations.