Characteristics of women with gynecologic cancer who enter clinical trials.

Objective: To determine if differences exist between gynecologic cancer patients who participate in clinical trials and those who do not.

Study Design: Two hundred thirty-six subjects with gynecologic cancer diagnosed between 1997 and 2001 were identified. Multiple clinical and demographic factors, including clinical trial enrollment, postoperative treatment and related complications, were recorded.

Results: Fifty-four women with gynecologic cancer were enrolled to National Cancer Institute-approved clinical trials, while 182 were not enrolled. Differences between those 2 groups in age, ethnicity, primary residence and related complications were not significant. Subjects enrolled had more blood tests, imaging studies and adjuvant therapy than those not enrolled. Endometrial (p = 0.014) and ovarian (p < 0.001) cancer patients with inadequate initial surgery were less likely to enter clinical trials. Endometrial (p = 0.012) and ovarian (p = 0.001) patients who had a gynecologic oncologist as the initial surgeon were more likely to enter clinical trials.

Conclusion: The most important factor affecting clinical trial participation appears to be the patients' level of familiarity with the physician-investigator who describes the trial. Earlier involvement of gynecologic oncologists in patient care and/or facilitating access to clinical trials by nongynecologic oncologists should increase patient enrollment.