A Phase III Randomized Trial of Pulse Actinomycin-D Versus Multi-day Methotrexate for the Treatment of Low-Risk Gestational Trophoblastic Neoplasia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 289
- 主要终点
- Percentage of Participants With Complete Response
研究概览
简要总结
This randomized phase III trial studies how well methotrexate works compared to dactinomycin in treating patients with low-risk gestational trophoblastic neoplasia. Drugs used in chemotherapy, such as methotrexate and dactinomycin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether methotrexate is more effective than dactinomycin in treating gestational trophoblastic disease.
详细描述
PRIMARY OBJECTIVES:
I. To test the hypothesis that treatment with multi-day methotrexate is inferior to treatment with pulse actinomycin-D (dactinomycin) in patients with low-risk gestational trophoblastic disease with respect to complete response.
SECONDARY OBJECTIVES:
I. To describe the frequency of post protocol surgical treatment for each arm. II. To describe the frequency of post protocol multi-agent chemotherapy treatment for each arm.
III. To compare multi-day methotrexate to actinomycin-D with respect to frequency and severity of adverse events in patients with low-risk gestational trophoblastic neoplasia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who meet International Federation of Gynecology and Obstetrics (FIGO) stage I, II, or III criteria for low-risk gestational trophoblastic neoplasia (GTN): post molar GTN or choriocarcinoma (as defined below); patients may have had a second curettage but must still meet GTN criteria below:
- •Post molar GTN
- •For the purposes of this study, patients must have undergone evacuation of a complete or partial hydatidiform mole and then meet the criteria for GTN defined as:
- •A < 10% decrease in the hCG level using as a reference the first value in the series of 4 values taken over a period of 3 weeks (> 50 mIU/ml minimum) OR
- •A > 20% sustained rise in the hCG taking as a reference the first value in the series of 3 values taken over a period of 2 weeks (> 50 mIU/ml minimum) OR
- •A persistently elevated hCG level a period of 6 months or more following the initial curettage (> 50 mIU/ml minimum)
- •Choriocarcinoma
- •Histologically proven non-metastatic choriocarcinoma OR
- •Histologically proven metastatic choriocarcinoma if the metastatic site(s) is restricted to one (or more) of the following: vagina, parametrium, or lung
- •World Health Organization (WHO) risk score 0-6
- •Patients must be willing to practice effective contraception for the duration of the study
- •White blood cell count (WBC) >= 3,000 cells/mcL
- •Granulocytes >= 1,500/mcL
- •Platelets >= 100,000/mcL
- •Creatinine =< 2.0 mg/dcL
- •Bilirubin =< 1.5 x institutional normal
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x institutional normal
- •Alkaline phosphatase =< 3 x institutional normal
- •Patients who have met the pre-entry requirements
- •Before enrolling a patient, the institution must verify the availability of an adequate supply of methotrexate for a full course of therapy
- •Patients must have signed an approved informed consent and authorization permitting release of personal health information
排除标准
- •Patients who do not have GTN
- •Patients with non-gestational choriocarcinoma
- •Patients who have previously been treated with cytotoxic chemotherapy; however, patients who received prior low-dose methotrexate for treatment of an ectopic pregnancy will be eligible for this study
- •Patients who have received prior pelvic radiation
- •Patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)
- •Patients with Gynecologic Oncology Group (GOG) performance status of 3 or 4
- •Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
- •Patients whose circumstances at the time of study entry do not permit completion of the study or required follow-up
- •Patients who wish to breast-feed during treatment
研究组 & 干预措施
Arm I (dactinomcin)
Patients receive dactinomycin IV over 15 minutes on day 1.
干预措施: Dactinomycin (Biological)
Arm I (dactinomcin)
Patients receive dactinomycin IV over 15 minutes on day 1.
干预措施: Quality-of-Life Assessment (Other)
Arm II (leucovorin calcium and methotrexate)
Patients receive methotrexate IM on days 1, 3, 5, and 7 and leucovorin calcium PO on days 2, 4, 6, and 8 OR single agent methotrexate IV on days 1-5.
干预措施: Leucovorin Calcium (Drug)
Arm II (leucovorin calcium and methotrexate)
Patients receive methotrexate IM on days 1, 3, 5, and 7 and leucovorin calcium PO on days 2, 4, 6, and 8 OR single agent methotrexate IV on days 1-5.
干预措施: Methotrexate (Drug)
Arm II (leucovorin calcium and methotrexate)
Patients receive methotrexate IM on days 1, 3, 5, and 7 and leucovorin calcium PO on days 2, 4, 6, and 8 OR single agent methotrexate IV on days 1-5.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Percentage of Participants With Complete Response
时间窗: hCG testing is performed prior to each cycle to treatment until treatment is completed, up to 10 months. For patients who have responded to treatment hCG must be obtained every 4 weeks for 1 year after completing treatment.
Complete Response is defined as 3 consecutive bi-weekly values of hCG\<5 over a minimum of 4 weeks of normal hCG values with no values greater than 5 mIU/ml
次要结局
- Number of Participants With CTCAE v4 Graded Adverse Events With Low-risk Gestational Trophoblastic Neoplasia by Arm(Assessed throughout the treatment period and within 2-4 weeks after discontinuation of treatment)
- The Number of Participants With Post Protocol Surgical Treatment for Each Arm.(Anytime during post treatment follow-up for up to 2 years from study entry.)
- The Number of Participants With Post Protocol Multi-agent Chemotherapy Treatment for Each Arm.(Anytime during post treatment follow-up for up to 2 years from study entry.)
- Patient-reported Quality of Life (QOL) at Baseline(Prior to cycle 1)
- Patient-reported Quality of Life (QOL) After Baseline Visit.(Prior to cycle 3 (4 weeks after cycle 1 if off study treatment prior to cycle 3). Prior to cycle 5, Prior to cycle 7, 26 weeks after starting study treatment.)