Non-Metastatic Gestational Trophoblastic Tumor Clinical Trial
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
| Verified date | August 2017 |
| Source | Gynecologic Oncology Group |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 64 |
| Est. completion date | June 25, 2015 |
| Est. primary completion date | June 25, 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | N/A and older |
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Odette Cancer Centre- Sunnybrook Health Sciences Centre | Toronto | Ontario |
| United States | Abington Memorial Hospital | Abington | Pennsylvania |
| United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
| United States | Colorado Gynecologic Oncology Group | Aurora | Colorado |
| United States | University of Colorado Cancer Center - Anschutz Cancer Pavilion | Aurora | Colorado |
| United States | State University of New York Downstate Medical Center | Brooklyn | New York |
| United States | Northwestern University | Chicago | Illinois |
| United States | University of Cincinnati/Barrett Cancer Center | Cincinnati | Ohio |
| United States | Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
| United States | Parkland Memorial Hospital | Dallas | Texas |
| United States | UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas |
| United States | Gynecologic Oncology Network | Greenville | North Carolina |
| United States | Hartford Hospital | Hartford | Connecticut |
| 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 | Palo Alto Medical Foundation-Gynecologic Oncology | Mountain View | California |
| United States | The Hospital of Central Connecticut | New Britain | Connecticut |
| United States | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey |
| United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
| United States | Stanford Cancer Institute | Palo Alto | California |
| United States | Carilion Clinic Gynecological Oncology | Roanoke | Virginia |
| United States | UCSF Medical Center-Mount Zion | San Francisco | California |
| United States | Memorial University Medical Center | Savannah | Georgia |
| United States | Olive View-University of California Los Angeles Medical Center | Sylmar | California |
| United States | Oklahoma Cancer Specialists and Research Institute-Tulsa | Tulsa | Oklahoma |
| United States | Virtua Voorhees | Voorhees | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Gynecologic Oncology Group | National Cancer Institute (NCI) |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | ||
| Primary | Frequency of surgical cure defined as normal beta-hCG level documented for 6 consecutive months AND no chemotherapy | Up to 6 months | ||
| Primary | 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 | |
| Primary | 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00003702 -
Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia
|
Phase 3 |