A Phase II Study to Determine the Response to Second Curettage as Initial Management for Persistent Low Risk, Non-metastatic Gestational Trophoblastic Neoplasia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 29
- 主要终点
- Surgical failure, defined as the development of choriocarcinoma, placental site trophoblastic tumor, or epithelioid trophoblastic tumor histologically diagnosed at second curettage
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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) performance status of 0 or 1
- •Patients must have histologically confirmed complete or partial mole
- •Patients must agree to use an accepted method of contraception (oral contraceptives, birth control patches, Depo-Provera, diaphragm, contraceptive foam and condom, or male/female sterilization)
- •Patients must meet pre-entry requirements
排除标准
- •Patients who do not have persistent low-risk GTN
- •Patients with any evidence of metastatic disease beyond the uterus
- •Patients with persistent or recurrent GTN (same gestation) that have already been treated with chemotherapy
- •Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, patients who have had any evidence of the other cancer present within the last 5 years or patients whose previous cancer treatment contraindicates this protocol therapy
- •Patients with histologically confirmed choriocarcinoma, placental site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT) on the first curettage
- •Patients who refuse to use an accepted method of contraception
- •Patients who have had more than one curettage for the management of the current disease or who have undergone hysterectomy
研究组 & 干预措施
Treatment (second curettage)
Patients undergo a second curettage rather than standard treatment (immediate chemotherapy) within 14 days of registration.
干预措施: Laboratory Biomarker Analysis (Other)
Treatment (second curettage)
Patients undergo a second curettage rather than standard treatment (immediate chemotherapy) within 14 days of registration.
干预措施: Therapeutic Conventional Surgery (Procedure)
结局指标
主要结局
Surgical failure, defined as the development of choriocarcinoma, placental site trophoblastic tumor, or epithelioid trophoblastic tumor histologically diagnosed at second curettage
时间窗: At time of surgery
Frequency of surgical cure defined as normal beta-hCG level documented for 6 consecutive months AND no chemotherapy
时间窗: Up to 6 months
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
时间窗: Up to 6 months
Incidence of adverse effects of second curettage, assessed by Common Terminology Criteria for Adverse Events version 4.0
时间窗: 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.
次要结局
未报告次要终点