Second Curettage in Treating Patients With Persistent Non-metastatic Gestational Trophoblastic Tumors
August 23, 2017 updated by: Gynecologic Oncology Group
A Phase II Study to Determine the Response to Second Curettage as Initial Management for Persistent Low Risk, Non-metastatic Gestational Trophoblastic Neoplasia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M4N 3M5
- Odette Cancer Centre- Sunnybrook Health Sciences Centre
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-
-
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California
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Mountain View, California, United States, 94040
- Palo Alto Medical Foundation-Gynecologic Oncology
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Palo Alto, California, United States, 94304
- Stanford Cancer Institute
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San Francisco, California, United States, 94115
- UCSF Medical Center-Mount Zion
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Sylmar, California, United States, 91342
- Olive View-University of California Los Angeles Medical Center
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Cancer Center - Anschutz Cancer Pavilion
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Aurora, Colorado, United States, 80010
- Colorado Gynecologic Oncology Group
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-
Connecticut
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Hartford, Connecticut, United States, 06102
- Hartford Hospital
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New Britain, Connecticut, United States, 06050
- The Hospital of Central Connecticut
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Georgia
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Savannah, Georgia, United States, 31404
- Memorial University Medical Center
-
-
Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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Michigan
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Kalamazoo, Michigan, United States, 49007
- West Michigan Cancer Center
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Kalamazoo, Michigan, United States, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, United States, 49001
- Borgess Medical Center
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Nevada
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Las Vegas, Nevada, United States, 89169
- Women'S Cancer Center of Nevada
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New Jersey
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Mount Holly, New Jersey, United States, 08060
- Virtua Memorial
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New Brunswick, New Jersey, United States, 08903
- Rutgers Cancer Institute of New Jersey
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Voorhees, New Jersey, United States, 08043
- Virtua Voorhees
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New Mexico
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Albuquerque, New Mexico, United States, 87102
- University of New Mexico Cancer Center
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New York
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Brooklyn, New York, United States, 11203
- State University of New York Downstate Medical Center
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North Carolina
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Greenville, North Carolina, United States, 27834
- Gynecologic Oncology Network
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Ohio
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Cincinnati, Ohio, United States, 45219
- University of Cincinnati/Barrett Cancer Center
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Columbus, Ohio, United States, 43210
- Ohio State University Comprehensive Cancer Center
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma Health Sciences Center
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Tulsa, Oklahoma, United States, 74146
- Oklahoma Cancer Specialists and Research Institute-Tulsa
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Pennsylvania
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Abington, Pennsylvania, United States, 19001
- Abington Memorial Hospital
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Texas
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Dallas, Texas, United States, 75235
- Parkland Memorial Hospital
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Dallas, Texas, United States, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
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Virginia
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Roanoke, Virginia, United States, 24016
- Carilion Clinic Gynecological Oncology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Treatment (second curettage)
Patients undergo a second curettage rather than standard treatment (immediate chemotherapy) within 14 days of registration.
|
Correlative studies
Undergo second curettage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
Time Frame: Up to 6 months
|
Up to 6 months
|
|
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Frequency of surgical cure defined as normal beta-hCG level documented for 6 consecutive months AND no chemotherapy
Time Frame: Up to 6 months
|
Up to 6 months
|
|
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Incidence of adverse effects of second curettage, assessed by Common Terminology Criteria for Adverse Events version 4.0
Time Frame: 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.
|
Up to 30 days after the surgical procedure
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Surgical failure, defined as the development of choriocarcinoma, placental site trophoblastic tumor, or epithelioid trophoblastic tumor histologically diagnosed at second curettage
Time Frame: At time of surgery
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At time of surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Raymond Osborne, NRG Oncology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 9, 2007
Primary Completion (ACTUAL)
June 25, 2015
Study Completion (ACTUAL)
June 25, 2015
Study Registration Dates
First Submitted
August 24, 2007
First Submitted That Met QC Criteria
August 24, 2007
First Posted (ESTIMATE)
August 27, 2007
Study Record Updates
Last Update Posted (ACTUAL)
August 24, 2017
Last Update Submitted That Met QC Criteria
August 23, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GOG-0242 (OTHER: CTEP)
- U10CA180868 (U.S. NIH Grant/Contract)
- U10CA027469 (U.S. NIH Grant/Contract)
- NCI-2009-00606 (REGISTRY: CTRP (Clinical Trial Reporting Program))
- CDR0000561984
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.