A Pilot Safety and Toxicity Trial of Adjuvant Chemotherapy With Gemcitabine and Docetaxel and Radiation Therapy for Completely Resected Uterine Leiomyosarcoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Recurrence-free Survival
研究概览
简要总结
This pilot clinical trial studies gemcitabine hydrochloride, docetaxel, and radiation therapy in treating patients with uterine sarcoma that has been removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and docetaxel, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill tumor cells. Giving combination chemotherapy with radiation therapy may kill any tumor cells that remain after surgery.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the toxicity and tolerability of adjuvant pelvic radiation in combination with gemcitabine (gemcitabine hydrochloride)/docetaxel chemotherapy in patients with stage 1 and 2 surgically-resected uterine leiomyosarcoma.
SECONDARY OBJECTIVES:
I. To assess the two year recurrence-free survival in patients with uterine leiomyosarcoma treated with chemotherapy and radiation therapy including defining the patterns of recurrence in patients with uterine leiomyosarcoma who were treated with this regimen.
OUTLINE:
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically documented uterine leiomyosarcoma with no visible residual disease
- •Surgical staging to include total hysterectomy, +/- removal of ovaries and fallopian tubes, +/- lymph node sampling
- •Patients must be entered no more than 12 weeks post operatively
- •Eastern Cooperative Oncology Group (ECOG) performance status of < 2
- •Written voluntary informed consent
排除标准
- •Serum glutamic oxaloacetic transaminase (SGOT) and /or serum glutamate pyruvate transaminase (SGPT) > 2.5 times the institutional upper limit of normal
- •Total serum bilirubin > 1.5 mg/dl
- •History of chronic or active hepatitis
- •Serum creatinine > 2.0 mg/dl
- •Platelets < 100,000/mm3
- •Absolute neutrophil count (ANC) < 1500/mm3
- •Hemoglobin < 8.0 g/dl (the patient may be transfused prior to study entry)
- •Patients with severe or uncontrolled concurrent medical disease (eg. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.)
- •Patients with any prior chemotherapy or radiotherapy for pelvic malignancy
- •Patients who have had prior therapy with gemcitabine or docetaxel
- •Patients with known hypersensitivity to gemcitabine or docetaxel
- •Patients with known hypersensitivity to pegfilgrastim and filgrastim
- •Patients with any history of cancer with the exception of non-melanoma skin cancer are excluded if there is any evidence of other malignancy being present within the past five years
- •Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entry
研究组 & 干预措施
Treatment (gemcitabine, docetaxel, brachytherapy/IMRT, EBRT)
CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
RADIATION THERAPY: Beginning week 10, patients undergo 3 fractions of brachytherapy or IMRT over 3 weeks. Patients then undergo EBRT QD 5 days a week for 5 weeks.
干预措施: Gemcitabine Hydrochloride (Drug)
Treatment (gemcitabine, docetaxel, brachytherapy/IMRT, EBRT)
CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
RADIATION THERAPY: Beginning week 10, patients undergo 3 fractions of brachytherapy or IMRT over 3 weeks. Patients then undergo EBRT QD 5 days a week for 5 weeks.
干预措施: Docetaxel (Drug)
Treatment (gemcitabine, docetaxel, brachytherapy/IMRT, EBRT)
CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
RADIATION THERAPY: Beginning week 10, patients undergo 3 fractions of brachytherapy or IMRT over 3 weeks. Patients then undergo EBRT QD 5 days a week for 5 weeks.
干预措施: Internal Radiation Therapy (Radiation)
Treatment (gemcitabine, docetaxel, brachytherapy/IMRT, EBRT)
CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
RADIATION THERAPY: Beginning week 10, patients undergo 3 fractions of brachytherapy or IMRT over 3 weeks. Patients then undergo EBRT QD 5 days a week for 5 weeks.
干预措施: Intensity-Modulated Radiation Therapy (Radiation)
Treatment (gemcitabine, docetaxel, brachytherapy/IMRT, EBRT)
CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
RADIATION THERAPY: Beginning week 10, patients undergo 3 fractions of brachytherapy or IMRT over 3 weeks. Patients then undergo EBRT QD 5 days a week for 5 weeks.
干预措施: External Beam Radiation Therapy (Radiation)
Treatment (gemcitabine, docetaxel, brachytherapy/IMRT, EBRT)
CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
RADIATION THERAPY: Beginning week 10, patients undergo 3 fractions of brachytherapy or IMRT over 3 weeks. Patients then undergo EBRT QD 5 days a week for 5 weeks.
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
Recurrence-free Survival
时间窗: Date of entry to date of reappearance of disease, assessed at 2 years. The study was terminated prior to analyses
Two-year recurrence-free survival probability will be estimated, with 95% confidence limits based on exact methods for the binomial distribution. In the event of censoring before two years, a Kaplan-Meier estimate of the survival probability will be used and a Kaplan-Meier survival curve will be estimated and presented as well. The study was terminated prior to analyses
次要结局
未报告次要终点