CompletedPhase 2

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

United States, Canada64 participantsStarted 2007-10-09

Plain-language 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.

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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) perfo…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Up to 6 months

Frequency of surgical cure defined as normal beta-hCG level documented for 6 consecutive months AND no chemotherapy

Timeframe: Up to 6 months

Incidence of adverse effects of second curettage, assessed by Common Terminology Criteria for Adverse Events version 4.0

Timeframe: Up to 30 days after the surgical procedure

Surgical failure, defined as the development of choriocarcinoma, placental site trophoblastic tumor, or epithelioid trophoblastic tumor histologically diagnosed at second curettage

Timeframe: At time of surgery

Trial details

NCT IDNCT00521118

SponsorGynecologic Oncology Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2015-06-25

View on ClinicalTrials.gov More Complete Hydatidiform Mole trials

Plain-language summary

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Up to 6 months

Frequency of surgical cure defined as normal beta-hCG level documented for 6 consecutive months AND no chemotherapy

Timeframe: Up to 6 months

Incidence of adverse effects of second curettage, assessed by Common Terminology Criteria for Adverse Events version 4.0

Timeframe: Up to 30 days after the surgical procedure

Surgical failure, defined as the development of choriocarcinoma, placental site trophoblastic tumor, or epithelioid trophoblastic tumor histologically diagnosed at second curettage

Timeframe: At time of surgery