A Randomized Phase III Trial of Weekly Parenteral Methotrexate Versus "Pulsed" Dactinomycin as Primary Management for Low Risk Gestational Trophoblastic Neoplasia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0
研究概览
简要总结
Randomized phase III trial to compare the effectiveness of methotrexate with that of dactinomycin in treating patients who have gestational trophoblastic neoplasia. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether methotrexate is more effective than dactinomycin in treating patients with gestational trophoblastic neoplasia.
详细描述
OBJECTIVES:
I. Compare the efficacy of methotrexate vs dactinomycin, as measured by complete response rate, in patients with low-risk gestational trophoblastic neoplasia.
II. Compare the toxicity of these regimens in these patients. III. Determine whether the definition of persistent gestational trophoblastic neoplasia is accurate (as determined by the likelihood that the beta human chorionic gonadotropin [HCG] titer would decline on the day treatment is initiated).
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive methotrexate intramuscularly once weekly in the absence of disease progression or unacceptable toxicity.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically proven low-risk gestational trophoblastic neoplasia (persistent hydatidiform mole or choriocarcinoma), defined as 1 of the following:
- •Less than 10% decrease in the beta human chorionic gonadotropin (HCG) titer over 3 weekly titers
- •Greater than 20% sustained rise in beta HCG titer over two consecutive weeks
- •Persistently elevated beta HCG titer more than 4 months after initial curettage (greater than 5 mIU/mL minimum)
- •Histologically proven nonmetastatic choriocarcinoma
- •Metastases to vagina, parametria, or lung (if no single pulmonary lesion is greater than 2 cm)
- •WHO score 0-6 (not including blood group or CT lung)
- •No histologically confirmed placental site pseudotumor
- •Must have undergone at least 1 uterine curettage
- •Previously untreated disease
- •Performance status - GOG 0-2
- •WBC at least 3,000/mm^3
- •Granulocyte count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •SGPT and SGOT no greater than 3 times ULN
- •Alkaline phosphatase no greater than 3 times ULN
- •No significant prior abnormal hepatic function
- •Creatinine no greater than 2.0 mg/dL
- •No significant prior abnormal renal function
- •Not pregnant or nursing
- •Fertile patients must use effective contraception during and for one year after study entry
- •No other prior or concurrent malignancies within the past 5 years except nonmelanomatous skin cancer
- •No prior chemotherapy for gestational trophoblastic neoplasia
- •No concurrent curettage except as needed to control vaginal bleeding or to rule out placental site pseudotumor
排除标准
- 未提供
研究组 & 干预措施
Arm I (methotrexate)
Patients receive methotrexate intramuscularly once weekly in the absence of disease progression or unacceptable toxicity. Patients continue on treatment until 1 beta HCG titer is below the institutional normal. Patients then receive 1 additional consolidation treatment.
干预措施: Methotrexate (Drug)
Arm II (dactinomycin)
Patients receive dactinomycin IV over 15 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients continue on treatment until 1 beta HCG titer is below the institutional normal. Patients then receive 1 additional consolidation treatment.
干预措施: Dactinomycin (Biological)
结局指标
主要结局
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0
时间窗: Prior to study entry, weekly during treatment, up to 12 months after normal titer, an average of 7 months.
Number of participants with a maximum grade of 3 or higher during the treatment period.
Response Based on Blood Human Chorionic Gonadotropin (hCG) Assay
时间窗: Endpoint was assessed by hCG measurements taken weekly, once normal, treatment was bi-weekly, then monthly, up to 12 months.
Primary outcome is measured as a difference in proportion responding between treatment arms and evaluated using a chi square test. A complete response was defined as a normal hCG sustained over four weekly measurements.
次要结局
- Number of Patients With a Decline of hCG on Day 1 of Treatment(Prior to study entry and on Day 1 of treatment)