Doctoral CRP on Clinical and Experimental Studies to Improve Radiotherapy Outcome in AIDS Cancer Patients
试验速览
- 阶段
- 3 期
- 入组人数
- 322
- 试验地点
- 5
- 主要终点
- 3 year recurrence free survival
研究概览
简要总结
The researchers plan:
- To undertake clinical studies of radiotherapy with or without the administration of the chemotherapeutic agent cisplatin, known to be a radiosensitizer;
- To perform pre-clinical studies of the radiosensitivity of human fibroblasts and cervical cancer cell lines in culture, with or without the addition of various HIV proteins or protease inhibitors, in order to determine the extent of any cellular radiosensitizing properties of these molecules;
- To develop strategies for sensitizing tumour cells to radiation, specifically by down-regulating specific viral proteins that are known to be factors associated with resistance to radiotherapy.
详细描述
Clinical study addresses the question of whether radiotherapy plus weekly cisplatin offers an advantage over the same radiotherapy given alone in AIDS patients with cervix cancer. External beam radiotherapy is used with 50 Gy in 25 daily fractions (last interim analysis, October 2005) suggested lowering the total dose down to 46 Gy in 23 daily fractions). Brachytherapy component was specified as either 30 Gy of LDR in a single fraction or 3 fractions of 8 Gy using HDR. Cisplatin was administered weekly at a dose of 30 mg/sqm.
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
- •Cancer of the cervix
排除标准
- •Unable to give informed consent
研究组 & 干预措施
Radiotherapy alone
EBRT pelvis 46 Gy, 4 field box technique + ICBT LDR 1x30 Gy/A or HDR 3x8 Gy/A
干预措施: Radiotherapy alone (Radiation)
Radiotherapy plus Chemotherapy
EBRT pelvis 46 Gy, 4 field box technique + ICBT LDR 1x30 Gy/A or HDR 3x8 Gy/A + weekly cisplatin 30 mg/m2 during EBRT
干预措施: Radiotherapy with cisplatin (Radiation)
结局指标
主要结局
3 year recurrence free survival
时间窗: 3 years
次要结局
- Incidence of Grade 3 acute toxicity(3 months)
- Pelvic control rates(3 years)
- Tumour response at 3 months.(3 months)
- Cancer specific survival rates.(3 years)
- Overall survival rates.(3 years)
- Acute and late toxicities after the treatment.(up to 3 years)