Clinical Trial: Second Curettage in Treating Patients With Persistent Non-metastatic Gestational Trophoblastic Tumors

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Gynecologic Oncology Group

Current Primary Outcome:

  • 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 [ Time Frame: Up to 6 months ]
  • Frequency of surgical cure defined as normal beta-hCG level documented for 6 consecutive months AND no chemotherapy [ Time Frame: Up to 6 months ]
  • Incidence of adverse effects of second curettage, assessed by Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 30 days after the surgical procedure ]
    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.
  • Surgical failure, defined as the development of choriocarcinoma, placental site trophoblastic tumor, or epithelioid trophoblastic tumor histologically diagnosed at second curettage [ Time Frame: At time of surgery ]


Original Primary Outcome:

  • Frequency of surgical cure, defined a normal beta-human chorionic gonadotropin (hCG) level documented for 6 consecutive months AND no chemotherapy
  • Development of choriocarcinoma, placental site trophoblastic tumor (PSTT), or epithelioid trophoblastic tumor (ETT) histologically diagnosed at second curettage
  • 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
  • Frequency and severity of adverse effects of second curettage, specifically uterine operative injury, hemorrhage, and infection (pelvis, fallopian tubes, and ovaries), as assessed by CTCAE version 3.0


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Gynecologic Oncology Group

Dates:
Date Received: August 24, 2007
Date Started: October 2007
Date Completion:
Last Updated: May 3, 2017
Last Verified: May 2017