A Phase II Study to Determine the Response to Second Curettage as Initial Management for Persistent Low Risk, Non-Metastatic Gestational Trophoblastic Neoplasia
- To determine the response to second curettage in patients with persistent,
non-metastatic gestational trophoblastic neoplasia (GTN).
- 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
- 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).
- 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.
- To estimate the frequency of a change in the uterine histology between the first and
OUTLINE: This is a multicenter study.
Patients undergo a second curettage rather than standard treatment (immediate chemotherapy).
Patients whose disease has transformed into choriocarcinoma, placental site trophoblastic
tumor, or epithelioid trophoblastic tumor (histologically diagnosed at the second curettage)
are removed from the study. All other patients undergo weekly beta-human chorionic
gonadotropin (hCG) testing beginning 14 days after the second curettage and continuing until
the beta-hCG level is normal. Patients then undergo further beta-HCG testing weekly for 4
weeks and then monthly for 5 months. If the level does not regress to normal, or rises, or
if metastatic disease is identified, the patient is removed from the study.
Masking: Open Label, Primary Purpose: Treatment
Frequency of surgical cure, defined a normal beta-human chorionic gonadotropin (hCG) level documented for 6 consecutive months AND no chemotherapy
Raymond Osborne, MD, FRCSC, MBA
Edmond Odette Cancer Centre at Sunnybrook
|Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|Charles M. Barrett Cancer Center at University Hospital||Cincinnati, Ohio 45267-0526|
|Lake/University Ireland Cancer Center||Mentor, Ohio 44060|
|Carilion Gynecologic Oncology Associates||Roanoke, Virginia 24014|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||Dallas, Texas 75390|
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|
|Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center||Savannah, Georgia 31403-3089|
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School||New Brunswick, New Jersey 08903|
|University of New Mexico Cancer Center||Albuquerque, New Mexico 87131-5636|
|Oklahoma University Cancer Institute||Oklahoma City, Oklahoma 73104|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|
|Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton||Marlton, New Jersey 08053|
|Fox Chase Virtua Health Cancer Program at Virtua West Jersey||Voorhees, New Jersey 08043|
|Cancer Care Associates - Saint Francis Campus||Tulsa, Oklahoma 74136-1929|
|Rosenfeld Cancer Center at Abington Memorial Hospital||Abington, Pennsylvania 19001|
|Parkland Memorial Hospital||Dallas, Texas 75235|
|Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center||Columbus, Ohio 43210-1240|
|Women's Cancer Center - La Canada||Las Vegas, Nevada 89169|
|University of Colorado Cancer Center at UC Health Sciences Center||Aurora, Colorado 80045|