Second Curettage in Treating Patients With Persistent Non-metastatic Gestational Trophoblastic Tumors
A Phase II Study to Determine the Response to Second Curettage as Initial Management for Persistent Low Risk, Non-metastatic Gestational Trophoblastic Neoplasia
5 other identifiers
interventional
64
2 countries
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2007
Longer than P75 for phase_2
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2007
CompletedFirst Posted
Study publicly available on registry
August 27, 2007
CompletedStudy Start
First participant enrolled
October 9, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 25, 2015
CompletedAugust 24, 2017
August 1, 2017
7.7 years
August 24, 2007
August 23, 2017
Conditions
Outcome Measures
Primary Outcomes (4)
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
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
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
Study Arms (1)
Treatment (second curettage)
EXPERIMENTALPatients undergo a second curettage rather than standard treatment (immediate chemotherapy) within 14 days of registration.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynecologic Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (29)
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, 94040, United States
Stanford Cancer Institute
Palo Alto, California, 94304, United States
UCSF Medical Center-Mount Zion
San Francisco, California, 94115, United States
Olive View-University of California Los Angeles Medical Center
Sylmar, California, 91342, United States
Colorado Gynecologic Oncology Group
Aurora, Colorado, 80010, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, 80045, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
Memorial University Medical Center
Savannah, Georgia, 31404, United States
Northwestern University
Chicago, Illinois, 60611, United States
Borgess Medical Center
Kalamazoo, Michigan, 49001, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89169, United States
Virtua Memorial
Mount Holly, New Jersey, 08060, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Virtua Voorhees
Voorhees Township, New Jersey, 08043, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102, United States
State University of New York Downstate Medical Center
Brooklyn, New York, 11203, United States
Gynecologic Oncology Network
Greenville, North Carolina, 27834, United States
University of Cincinnati/Barrett Cancer Center
Cincinnati, Ohio, 45219, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Parkland Memorial Hospital
Dallas, Texas, 75235, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
Carilion Clinic Gynecological Oncology
Roanoke, Virginia, 24016, United States
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Related Publications (1)
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.
PMID: 27500329DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raymond Osborne
NRG Oncology
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2007
First Posted
August 27, 2007
Study Start
October 9, 2007
Primary Completion
June 25, 2015
Study Completion
June 25, 2015
Last Updated
August 24, 2017
Record last verified: 2017-08