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Second Curettage in Treating Patients With Persistent Non-metastatic Gestational Trophoblastic Tumors
Not Recruiting
Trial ID: NCT00521118
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
Stanford Investigator(s)
Jonathan S. Berek, MD, MMSc
Laurie Kraus Lacob Professor
Eligibility
Inclusion 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
Exclusion Criteria:
- 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
Intervention(s):
other: laboratory biomarker analysis
procedure: Therapeutic Conventional Surgery
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061