Support is requested for participation in the cooperative clinical trials of the southeastern Cancer Study Group. Phase I studies of new schedules of dosage or new combinations of drugs or new combined modalities. The Group will not engage as a Group in initial toxicity studies of new agents. Phase II studies which may or may not be randomized of the effectiveness of a specific treatment plan in a series of patients with a specific disease or diseases. When appropriate, these studies will be disease-oriented, especially in the signal tumor but we also intend to include broadspectrum studies of promising agents or combination. Phase III studies are randomized comparisons (double- blind, if feasible) of two or more treatment plans. The specific expertise of the Group in the past has been in hematologic malignancies. Emphasis has steadily shifted toward solid tumors which now account for a large and increasing proportion of our case accessions. A Radiation Therapy Committee has been formed, radiotherapists have been accepted as members and we expect combined modality approaches to increase. Immunotherapy protocols have been instituted and will be expanded as justified by increasing knowledge. Ancillary and pilot studies at one or more institutions are encouraged: 1) Preliminary studies which may lead to data justifying a Group study; 2) Basic investigations directed toward elucidating mechanisms of action or other aspects of treatment given in a Group protocol; 3) Studies directed at better methods of evaluation of results; 4) Studies to improve supportive care. Emphasis is placed upon thorough planning, careful review of data and statistically sound evaluation of results. Important secondary benefits of these studies are the excellence of patient care and improved training of house officers and medical students.
NIH ExPorter
NIH ExPorter