Second Curettage in Treating Patients With Persistent Non-metastatic Gestational Trophoblastic Tumors
NCT ID: NCT00521118
Last Updated: 2017-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
64 participants
INTERVENTIONAL
2007-10-09
2015-06-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (second curettage)
Patients undergo a second curettage rather than standard treatment (immediate chemotherapy) within 14 days of registration.
Laboratory Biomarker Analysis
Correlative studies
Therapeutic Conventional Surgery
Undergo second curettage
Interventions
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Laboratory Biomarker Analysis
Correlative studies
Therapeutic Conventional Surgery
Undergo second curettage
Eligibility Criteria
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Inclusion 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 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
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Raymond Osborne
Role: PRINCIPAL_INVESTIGATOR
NRG Oncology
Locations
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Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, United States
Stanford Cancer Institute
Palo Alto, California, United States
UCSF Medical Center-Mount Zion
San Francisco, California, United States
Olive View-University of California Los Angeles Medical Center
Sylmar, California, United States
Colorado Gynecologic Oncology Group
Aurora, Colorado, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
The Hospital of Central Connecticut
New Britain, Connecticut, United States
Memorial University Medical Center
Savannah, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Borgess Medical Center
Kalamazoo, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, 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 Township, 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
University of Cincinnati/Barrett Cancer Center
Cincinnati, Ohio, 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
Countries
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References
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Osborne RJ, Filiaci VL, Schink JC, Mannel RS, Behbakht K, Hoffman JS, Spirtos NM, Chan JK, Tidy JA, Miller DS. Second Curettage for Low-Risk Nonmetastatic Gestational Trophoblastic Neoplasia. Obstet Gynecol. 2016 Sep;128(3):535-542. doi: 10.1097/AOG.0000000000001554.
Other Identifiers
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NCI-2009-00606
Identifier Type: REGISTRY
Identifier Source: secondary_id
GOG-0242
Identifier Type: -
Identifier Source: secondary_id
CDR0000561984
Identifier Type: -
Identifier Source: secondary_id
GOG-0242
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0242
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0242
Identifier Type: -
Identifier Source: org_study_id
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