Phase II Trial of Short VAC1.2 Therapy for Low-Risk A Group Patients With Rhabdomyosarcoma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 32
- 试验地点
- 102
- 主要终点
- Disease-free survival as measured by Kaplan-Meier method 3 years after study entry
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as vincristine, dactinomycin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving vincristine, dactinomycin, and cyclophosphamide together with or without radiation therapy works in treating patients with embryonal rhabdomyosarcoma.
详细描述
OBJECTIVES:
- Determine the progression-free survival rate in patients with low-risk embryonal rhadomyosarcoma treated with a shortened treatment schedule of vincristine, dactinomycin, and cyclophosphamide with or without radiotherapy.
OUTLINE: Patients receive vincristine IV, dactinomycin IV, and cyclophosphamide IV. Patients may also undergo radiotherapy. Treatment repeats every 3 weeks for up to 8 courses (total of 24 weeks) in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of embryonal rhabdomyosarcoma
- •Primary operation for pathological diagnosis within the past 42 days
- •The following variants are eligible:
- •Spindle cell
- •Anaplastic
- •Meets 1 of the following stage criteria:
- •Stage I, clinical group I or II (N0), defined by all of the following criteria:
- •Favorable site, including orbit, head, and neck (excluding parameningeal sites), genitourinary region (excluding bladder/prostate sites), or biliary tract
- •Tumor any size
- •Completely resected disease OR microscopic residual disease
- •Lymph nodes clinically negative
- •Stage I, clinical group III (N0), defined by all of the following criteria:
- •Favorable site
- •Tumor any size
- •Gross residual disease allowed (orbit only)
- •Lymph nodes clinically negative
- •Stage II, clinical group I (N0, Nx), defined by all of the following criteria:
- •Unfavorable site (any sites not listed as favorable sites)
- •Tumor ≤ 5 cm in diameter
- •Completely resected disease
- •Lymph nodes clinically negative OR lymph node involvement unknown
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC ≥ 2,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 7.5 g/dL
- •SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)
- •Bilirubin ≤ 2.5 times ULN
- •Bile acid ≤ 2.5 times ULN
- •Creatinine based on age as follows:
- •< 0.8 mg/dL (for patients < 5 years of age)
- •< 1.2 mg/dL (for patients 5-9 years of age)
- •< 1.5 mg/dL (for patients ≥ 10 years of age)
- •Cardiovascular
- •No severe heart disease
- •Not pregnant or nursing
- •Must have acceptable organ function for age
- •No uncontrolled infection
- •No other active malignancy
- •No other treated malignancy within the past 5 years
- •No hypersensitivity to study drugs
- •No Charcot-Marie-Tooth disease
- •No chickenpox
- •PRIOR CONCURRENT THERAPY:
- •Chemotherapy
- •No prior anticancer chemotherapy
- 另有 5 项未显示
排除标准
- 未提供
结局指标
主要结局
Disease-free survival as measured by Kaplan-Meier method 3 years after study entry
次要结局
- Overall survival as measured by Kaplan-Meier method 3 years after study entry
- Progression-free survival as measured by Kaplan-Meier method during events
- Complete response rate (orbit, group III only) at completion of study treatment
- Rate of toxicity as measured by NCI-CTC v 2.0 3 years after study entry