Phase I Toxicity Trial of Doxorubicin-Cisplatin Followed by Whole Abdominal Irradiation for Advanced Endometrial Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Frequency of severe and life threatening bowel, hepatic, and hematologic toxicity as assessed by CTEP CTC version 2.0
研究概览
简要总结
Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating women who have stage III or stage IV endometrial cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.
详细描述
OBJECTIVES:
I. Determine the feasibility of doxorubicin and cisplatin followed by whole abdominal radiotherapy in patients with stage III or IV endometrial cancer.
II. Determine the acute and chronic toxic effects, in particular, severe and life-threatening gastrointestinal, hepatic, and hematologic toxic effects, of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive doxorubicin IV and cisplatin IV on day 1. Treatment repeats every 3 weeks for 3 courses. Patients then undergo whole abdominal radiotherapy 5 days a week for 4-6 weeks.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed endometrial cancer including 1 of the following subtypes:
- •Clear cell carcinoma
- •Serous papillary carcinoma
- •Endometrioid adenocarcinoma
- •Stage III or IV disease
- •Positive adnexa
- •Metastases to serosa, bowel mucosa, abdomen
- •Positive pelvic or paraaortic nodes
- •Positive pelvic washings or vaginal involvement within the radiation port
- •Tumor must be surgically reduced to 2 cm or less within 8 weeks of study entry
- •Must have had a hysterectomy and bilateral salpingo oophorectomy
- •No recurrent disease
- •No distant metastases outside of abdominopelvic area, including:
- •Parenchymal liver metastases
- •Lung metastases
- •Positive inguinal lymph nodes
- •Positive supraclavicular nodes
- •Pleural effusion with malignant cytology
- •Performance status - GOG 0-2
- •Absolute neutrophil 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)
- •SGOT and alkaline phosphatase no greater than 3 times ULN
- •Creatinine no greater than ULN
- •Cardiac ejection fraction greater than 50%
- •No other prior or concurrent malignancy within the past 5 years except nonmelanoma skin cancer
- •No prior chemotherapy
- •No prior pelvic or abdominal radiotherapy
- •No prior radiotherapy for other prior malignancy
排除标准
- 未提供
研究组 & 干预措施
Treatment (doxorubicin, cisplatin, radiation therapy)
Patients receive doxorubicin IV and cisplatin IV on day 1. Treatment repeats every 3 weeks for 3 courses. Patients then undergo whole abdominal radiotherapy 5 days a week for 4-6 weeks.
干预措施: Cisplatin (Drug)
Treatment (doxorubicin, cisplatin, radiation therapy)
Patients receive doxorubicin IV and cisplatin IV on day 1. Treatment repeats every 3 weeks for 3 courses. Patients then undergo whole abdominal radiotherapy 5 days a week for 4-6 weeks.
干预措施: Doxorubicin Hydrochloride (Drug)
Treatment (doxorubicin, cisplatin, radiation therapy)
Patients receive doxorubicin IV and cisplatin IV on day 1. Treatment repeats every 3 weeks for 3 courses. Patients then undergo whole abdominal radiotherapy 5 days a week for 4-6 weeks.
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
Frequency of severe and life threatening bowel, hepatic, and hematologic toxicity as assessed by CTEP CTC version 2.0
时间窗: Up to 9 weeks
Number of patients completing the prescribed therapy
时间窗: Up to 9 weeks
Frequency and severity of acute adverse effects as assessed by CTEP CTC version 2.0
时间窗: 3 weeks
Frequency and severity of chronic adverse effects as assessed by CTEP CTC version 2.0
时间窗: Up to 5 years after completion of study treatment
次要结局
- Reason for discontinuing study therapy(Up to 9 weeks)