Spots Global Cancer Trial Database for Second Curettage in Treating Patients With Persistent Non-metastatic Gestational Trophoblastic Tumors
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Trial Identification
Brief Title: Second Curettage in Treating Patients With Persistent Non-metastatic Gestational Trophoblastic Tumors
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
Study ID: NCT00521118
Study Description
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.
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.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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, 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
Contact Details
Name: Raymond Osborne
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR
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