GOG 0242

Trial name or title	Second Curettage in Treating Patients With Persistent Non‐Metastatic Gestational Trophoblastic Tumor
Methods	Mutlicentre Phase II study (NCT00521118)
Participants	Women with histologically confirmed gestational trophoblastic neoplasia (GTN) (complete or partial hydatidiform mole) with no histologically confirmed choriocarcinoma, placental site trophoblastic tumor (PSTT), or epithelioid trophoblastic tumour (ETT) on the first curettage. Persistent, low‐risk disease (based on FIGO/WHO 2002 staging and risk scoring criteria), as defined by 1 of the following criteria: Less than 10% decline in beta‐human chorionic gonadotropin (hCG) levels, based on four consecutive measurements over a 3‐week period (plateau); Greater than 20% rise in beta‐hCG levels, based on three consecutive measurements over a 2‐week period; Beta‐hCG level remains elevated above normal for ≥ 6 months. WHO risk score ≤ 6. Must have a clinically significant elevated beta‐hCG level of > 20 miu/mL. No evidence of metastatic disease beyond the uterus by pelvic examination, pelvic ultrasound, and chest x‐ray. No previously treated, persistent or recurrent GTN (same gestation) that have been treated with chemotherapy
Interventions	Patients undergo a second curettage rather than standard treatment (immediate chemotherapy). Patients whose disease has transformed into choriocarcinoma, placental site trophoblastic tumour, or epithelioid trophoblastic tumour (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.
Outcomes	Frequency of surgical cure, defined a normal beta‐human chorionic gonadotropin (hCG) level documented for 6 consecutive months AND no chemotherapy. Development of choriocarcinoma, placental site trophoblastic tumour (PSTT), or epithelioid trophoblastic tumour (ETT) histologically diagnosed at second curettage. 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. Frequency and severity of adverse effects of second curettage, specifically uterine operative injury, haemorrhage, and infection (pelvis, fallopian tubes, and ovaries), as assessed by CTCAE version 3.0.
Starting date	October 2007
Contact information	Philip J. DiSaia, Gynecologic Oncology Group
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