Gynecologic Oncologists: Surgeons and Oncologists? Evaluating the Clinical Trial Landscape by Intervention Type

Objectives: Clinical trials advance the standard of care in women with gynecologic malignancies. The aim of this study is to evaluate the types of trials being offered and the distribution of intervention type across disease site and geographic location. Methods: Clinical trials in gynecologic oncology were identified by searching ClinicalTrials.gov for the following cancer types: ovarian, uterine, endometrial, cervical, vaginal, and vulvar. Data collection was performed in February 2020. Data on these trials were downloaded from the website and supplemented with manual codification. We excluded trials that were currently active, duplicative and/or not enrolling patients with gynecologic malignancies. Descriptive statistics were calculated. Results: A total of 1882 trials met inclusion criteria; the majority of trials enrolled patients with ovarian cancer (n=1174), followed by cervical (n=585), endometrial (n=457), vulvar (n=102), and vaginal cancer (n=92), although trials often enrolled multiple disease sites. Drug/biologic interventions were most commonly evaluated accounting for 75.2% (n=1415) of trials. Of these, 340 (24.0%) enrolled patients with cervical cancer, and 989 (69.9%) enrolled patients with ovarian cancer. Overall, 7.2% (n=136) of trials involved a procedural or surgical intervention, the majority of which were related to cervical (n=56, 41.2%), endometrial (n=42, 30.9%), and ovarian (n=47, 34.6%) cancers (Figure 1). Trials were further divided into whether patients were enrolled within the United States and/or internationally. Procedural trials comprised 4.2% (n=45) of total trials domestically and 11.2% (n=91) internationally. The largest proportion of domestic procedural cancer trials enrolled patients with endometrial (n=15, 33.3%) and cervical cancers (n=14, 31.1%). International procedural trials were more likely to enroll patients with cervical (n=42, 46.2%) and ovarian cancers (n=29, 31.9%). Most clinical trials evaluated a therapeutic strategy (n=1389, 73.8%), but other open trials evaluated methods of prevention (n=170, 9.0%), supportive care options (n=119, 6.3%), and diagnosis (n=109, 5.8%). Conclusions: Clinical trials available to patients with gynecologic malignancies most commonly evaluate a biologic or drug rather than a surgical intervention. More trials evaluating a surgery or procedure were open internationally. As the field of gynecologic oncology evolves, it will be critical to ensure the interventions being evaluated maximally impact patient outcomes. Clinical trials advance the standard of care in women with gynecologic malignancies. The aim of this study is to evaluate the types of trials being offered and the distribution of intervention type across disease site and geographic location. Clinical trials in gynecologic oncology were identified by searching ClinicalTrials.gov for the following cancer types: ovarian, uterine, endometrial, cervical, vaginal, and vulvar. Data collection was performed in February 2020. Data on these trials were downloaded from the website and supplemented with manual codification. We excluded trials that were currently active, duplicative and/or not enrolling patients with gynecologic malignancies. Descriptive statistics were calculated. A total of 1882 trials met inclusion criteria; the majority of trials enrolled patients with ovarian cancer (n=1174), followed by cervical (n=585), endometrial (n=457), vulvar (n=102), and vaginal cancer (n=92), although trials often enrolled multiple disease sites. Drug/biologic interventions were most commonly evaluated accounting for 75.2% (n=1415) of trials. Of these, 340 (24.0%) enrolled patients with cervical cancer, and 989 (69.9%) enrolled patients with ovarian cancer. Overall, 7.2% (n=136) of trials involved a procedural or surgical intervention, the majority of which were related to cervical (n=56, 41.2%), endometrial (n=42, 30.9%), and ovarian (n=47, 34.6%) cancers (Figure 1). Trials were further divided into whether patients were enrolled within the United States and/or internationally. Procedural trials comprised 4.2% (n=45) of total trials domestically and 11.2% (n=91) internationally. The largest proportion of domestic procedural cancer trials enrolled patients with endometrial (n=15, 33.3%) and cervical cancers (n=14, 31.1%). International procedural trials were more likely to enroll patients with cervical (n=42, 46.2%) and ovarian cancers (n=29, 31.9%). Most clinical trials evaluated a therapeutic strategy (n=1389, 73.8%), but other open trials evaluated methods of prevention (n=170, 9.0%), supportive care options (n=119, 6.3%), and diagnosis (n=109, 5.8%). Clinical trials available to patients with gynecologic malignancies most commonly evaluate a biologic or drug rather than a surgical intervention. More trials evaluating a surgery or procedure were open internationally. As the field of gynecologic oncology evolves, it will be critical to ensure the interventions being evaluated maximally impact patient outcomes.