Second Curettage in Treating Patients With Persistent Non-Metastatic Gestational Trophoblastic Tumor

• Frequency of surgical cure, defined a normal beta-human chorionic gonadotropin (hCG) level documented for 6 consecutive months AND no chemotherapy [ Designated as safety issue: No ]
  
• Development of choriocarcinoma, placental site trophoblastic tumor (PSTT), or epithelioid trophoblastic tumor (ETT) histologically diagnosed at second curettage [ Designated as safety issue: No ]
  
• Development of "second persistent" disease, defined as failure to achieve or maintain a normal assay, or a plateau, or a rise in the assay level after second curettage [ Designated as safety issue: No ]
  
• Frequency and severity of adverse effects of second curettage, specifically uterine operative injury, hemorrhage, and infection (pelvis, fallopian tubes, and ovaries), as assessed by CTCAE version 3.0 [ Designated as safety issue: Yes ]
  

OBJECTIVES:

Primary

• To determine the response to second curettage in patients with persistent, non-metastatic gestational trophoblastic neoplasia (GTN).

Secondary

• To evaluate if response to a second curettage is independent of the tumor burden as measured by the quantitative beta-human chorionic gonadotropin (hCG) assay at study entry.
• To evaluate if response to a second curettage is independent of the depth of myometrial invasion as measured sonographically following the initial curettage but prior to study entry (when persistent disease is first diagnosed).
• To estimate the frequency of complications related to a second curettage, specifically infection of the fallopian tubes or ovaries, hemorrhage associated with curettage, or operative injury to the uterus.
• To estimate the frequency of a change in the uterine histology between the first and second curettage.

OUTLINE: This is a multicenter study.

Patients undergo a second curettage rather than standard treatment (immediate chemotherapy). Patients whose disease has transformed into choriocarcinoma, placental site trophoblastic tumor, or epithelioid trophoblastic tumor (histologically diagnosed at the second curettage) are removed from the study. All other patients undergo weekly beta-human chorionic gonadotropin (hCG) testing beginning 14 days after the second curettage and continuing until the beta-hCG level is normal. Patients then undergo further beta-HCG testing weekly for 4 weeks and then monthly for 5 months. If the level does not regress to normal, or rises, or if metastatic disease is identified, the patient is removed from the study.