Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT00521118
Status:
COMPLETED
Last Update Posted:
2017-08-24
First Post:
2007-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Second Curettage in Treating Patients With Persistent Non-metastatic Gestational Trophoblastic Tumors
Sponsor:
Gynecologic Oncology Group
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2009-00606 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| GOG-0242 | None | None | View | |
| CDR0000561984 | None | None | View | |
| GOG-0242 | OTHER | NRG Oncology | View | |
| GOG-0242 | OTHER | CTEP | View | |
| U10CA180868 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10CA027469 | NIH | None | https://reporter.nih.gov/quic… | View |