COOPERATIVE STUDIES IN CANCER THERAPY
Funded Grant
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Overview
description
Major effort will be with the SECSG in cooperative human clinical chemotherapy trials. Solid tumors, limited and extensive; leukemias, acute and chronic; lymphomata; Hodgkin's and non-Hodgkin's type; and myeloma will be studied via studies of 3 types. Phase I - tolerance for and particularly of new agents or revised dosage schedules of combinations. Phase II - administration of a specific regimen (drugs and/or x-irradiation and/or biologic response modifers) to enough patients with a particular neoplasm to measure the effect of that therapy. Phase III - randomized comparisons of 2 or more treatment programs in advanced disease or limited disease (adjuvant therapy) using medical, surgical and radiation oncologic techniques. The group has a multidisciplinary approach to cancer treatment and includes surgical, radiation and medical oncologists as equal members and working in concert to design and implement protocols. Immunotherapy protocols have also been implemented. In addition, the importance of diagnosis and tumor characterization is recognized by the participation of the pathology group in protocol design and implementation where appropriate. 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 diagnosis or classification of disease under study on 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.
