Second Curettage in Treating Patients With Persistent Non-metastatic Gestational Trophoblastic Tumors
- Conditions
- Complete Hydatidiform MoleNon-Metastatic Gestational Trophoblastic TumorPartial Hydatidiform Mole
- Interventions
- Other: Laboratory Biomarker AnalysisProcedure: Therapeutic Conventional Surgery
- Registration Number
- NCT00521118
- Lead Sponsor
- Gynecologic Oncology Group
- Brief Summary
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.
- Detailed Description
PRIMARY OBJECTIVES:
I. To determine the response to second curettage in patients with persistent, non-metastatic gestational trophoblastic neoplasia (GTN).
SECONDARY OBJECTIVES:
I. 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.
II. 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).
III. 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.
IV. To estimate the frequency of a change in the uterine histology between the first and second curettage.
OUTLINE:
Patients undergo a second curettage rather than standard treatment (immediate chemotherapy) within 14 days of registration.
After completion of study treatment, patients are followed up at 14 days, weekly for 4 weeks, and then monthly for 5 months, and then every 3 months for 24 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 64
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment (second curettage) Therapeutic Conventional Surgery Patients undergo a second curettage rather than standard treatment (immediate chemotherapy) within 14 days of registration. Treatment (second curettage) Laboratory Biomarker Analysis Patients undergo a second curettage rather than standard treatment (immediate chemotherapy) within 14 days of registration.
- Primary Outcome Measures
Name Time Method Surgical failure, defined as the development of choriocarcinoma, placental site trophoblastic tumor, or epithelioid trophoblastic tumor histologically diagnosed at second curettage At time of surgery 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 Up to 6 months Frequency of surgical cure defined as normal beta-hCG level documented for 6 consecutive months AND no chemotherapy Up to 6 months Incidence of adverse effects of second curettage, assessed by Common Terminology Criteria for Adverse Events version 4.0 Up to 30 days after the surgical procedure The frequency and severity of the reported adverse effects of repeat evacuation will be tabulated. Specifically, uterine operative injury, hemorrhage, and infection (pelvis, fallopian tubes and ovaries) will be prospectively collected.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (29)
Women's Cancer Center of Nevada
🇺🇸Las Vegas, Nevada, United States
University of Cincinnati/Barrett Cancer Center
🇺🇸Cincinnati, Ohio, United States
Stanford Cancer Institute
🇺🇸Palo Alto, California, United States
UCSF Medical Center-Mount Zion
🇺🇸San Francisco, California, United States
Colorado Gynecologic Oncology Group
🇺🇸Aurora, Colorado, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion
🇺🇸Aurora, Colorado, United States
The Hospital of Central Connecticut
🇺🇸New Britain, Connecticut, United States
Palo Alto Medical Foundation-Gynecologic Oncology
🇺🇸Mountain View, California, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Memorial University Medical Center
🇺🇸Savannah, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Virtua Memorial
🇺🇸Mount Holly, New Jersey, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Virtua Voorhees
🇺🇸Voorhees, New Jersey, United States
University of New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
State University of New York Downstate Medical Center
🇺🇸Brooklyn, New York, United States
Gynecologic Oncology Network
🇺🇸Greenville, North Carolina, United States
Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
🇺🇸Tulsa, Oklahoma, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Parkland Memorial Hospital
🇺🇸Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas
🇺🇸Dallas, Texas, United States
Carilion Clinic Gynecological Oncology
🇺🇸Roanoke, Virginia, United States
Odette Cancer Centre- Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Borgess Medical Center
🇺🇸Kalamazoo, Michigan, United States
Olive View-University of California Los Angeles Medical Center
🇺🇸Sylmar, California, United States