Informed Consent and Some Problems in Clinical Trials of Postoperative Adjuvant Chemotherapy for Gastric Cancer

Keiichiro Ohta, Toshifusa Nakajima

Division of Surgery, Cancer Institute Hospital

Reasons for lack of registration for clinical trials of postoperative adjuvant che motherapy for gastric cancer are problems concerning informed consent, carelessness of physicians in charge, and incorrect preoperative diagnosis in more than half of the cases. It is consequently suggested that it is necessary to enlighten and educate personnel engaged in medical care including physicians in charge as well as patitents and their family and to create an appropriate environment. Sufficient attention should be paid to patients with advanced gastric cancer undergoing postoperative chemotherapy during a follow-up observation period, since the rate of patients receiving chemotherapy is low and that of patients receiving therapy after recurrence is sometimes lower, that compared with registered patients, for unregisterd patients. It is expected that results showing the usefulness of postoperative adjuvant chemotherapy in the treatment of advanced gastric cancer will be attained through adequate clinical trials.

Key words
informed consent, clinical trial, adjuvant chemotherapy of gastric cancer

Reprint requests
Keiichiro Ohta Division of Surgery, Cancer Institute Hospital
1-37-1 Kamiikebukuro, Toshima-ku, Tokyo, 170 JAPAN

Accepted
June 12, 1996

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