Second Curettage in Treating Patients With Persistent Non-metastatic Gestational Trophoblastic Tumors
Trial ID or NCT#
Status
NOT RECRUITING
Purpose
This phase II trial studies how well a second curettage (removal of the abnormal cancer cells in the uterus using a method of surgically removing the lining of the uterus) works in treating patients with gestational trophoblastic tumors that did not go away after a first curettage (persistent) and has not yet spread to other places in the body (non-metastatic). A second curettage may be effective in treating persistent gestational trophoblastic tumors and may decrease the likelihood that patients will need chemotherapy in the near future.
Official Title
A Phase II Study to Determine the Response to Second Curettage as Initial Management for Persistent Low Risk, Non-metastatic Gestational Trophoblastic Neoplasia
Eligibility Criteria
- - Patients who have had hydatidiform mole treated by evacuation and/or curettage and now meet the criteria of low risk GTN, as defined by the International Federation of Gynecology and Obstetrics (F.I.G.O.)/World Health Organization (W.H.O.) 2002 staging and risk scoring criteria: - A plateau in the beta-hCG assay for 4 consecutive weekly levels over a period of 3 weeks or longer; that is, days 1, 7, 14, 21; for this study, a plateau will be defined as less than a 10% decline using as a reference the initial value in the series of values taken over a period of 3 weeks; OR - A rise in the beta-hCG assay of 3 consecutive measurements, or longer, over at least a period of 2 weeks or more; days, 1, 7, 14; for this study, a rise will be defined as an increase of greater than 20% taking as a reference the initial value in the series of values taken over the 2-week period; OR - When the beta-hCG level remains elevated above normal for 6 months or longer - Patients must have a clinically significant elevated beta-hCG level of greater than 20 mIU/ml - Patients must have non-metastatic low risk GTN with a W.H.O. 2002 risk score of no greater than 6 - Patients must have no metastatic disease as determined by the pelvic examination, pelvic ultrasound, and chest x-ray - Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization - Patients must have a Gynecologic Oncology Group (GOG) performance status of 0 or 1 - Patients must have histologically confirmed complete or partial mole - Patients must agree to use an accepted method of contraception (oral contraceptives, birth control patches, Depo-Provera, diaphragm, contraceptive foam and condom, or male/female sterilization) - Patients must meet pre-entry requirements
- - Patients who do not have persistent low-risk GTN - Patients with any evidence of metastatic disease beyond the uterus - Patients with persistent or recurrent GTN (same gestation) that have already been treated with chemotherapy - Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, patients who have had any evidence of the other cancer present within the last 5 years or patients whose previous cancer treatment contraindicates this protocol therapy - Patients with histologically confirmed choriocarcinoma, placental site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT) on the first curettage - Patients who refuse to use an accepted method of contraception - Patients who have had more than one curettage for the management of the current disease or who have undergone hysterectomy
Investigator(s)
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Contact
Cancer Clinical Trials Office
650-498-7061
View on ClinicalTrials.gov
