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.


METHODS
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.


CONCLUSIONS
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.
Luck
Mindy B
MB
Department of Obstetrics and Gynecology, Texas Tech University/Harrington Cancer Center, Amarillo, Texas 79106, USA.
McIntire
Meredith
M
Blades
Nancy
N
Robinson
William
W
D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D016889:Endometrial Neoplasms / Q000453:epidemiology / Q000601:surgery / Q000628:therapy; D005260:Female; D005833:Genital Neoplasms, Female / Q000453:epidemiology* / Q000601:surgery / Q000628:therapy; D006801:Humans; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000453:epidemiology / Q000601:surgery / Q000628:therapy; D010358:Patient Participation / Q000706:statistics & numerical data*; D010817:Physician-Patient Relations; D012189:Retrospective Studies; D013781:Texas / Q000453:epidemiology; D002583:Uterine Cervical Neoplasms / Q000453:epidemiology / Q000601:surgery / Q000628:therapy