The Influence of the Pre-Therapeutic Increase in the Hemoglobin Level in the Blood Through Erythropoietin to the Therapy Results of the Primary Radiation Therapy for Carcinoma of the Cervix
试验速览
- 阶段
- 3 期
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- remission rate 3 months after completion of the radiation therapy
研究概览
简要总结
The purpose of this study is to determine whether an increase of blood haemoglobin levels through the substitution of erythropoietin during radiotherapy treatment of cervix cancer patients results in improvement for disease specific survival, tumor response and local control.
详细描述
Definitive radiotherapy is the treatment of choice for patients with locally advanced cervix cancer. Low pre-therapeutic values of the intratumoral pO2 are associated with significantly worse therapeutic outcome and the blood hemoglobin levels correlate positively with the intratumoral pO2. Successful augmentation of hemoglobin levels by way of transfusion leads to improvement of therapeutic results. Therefore, a pre-therapeutic transfusion therapy is carried out routinely at a number of hospitals; however this therapy is due to its cost and risks limited to patients with an initial hemoglobin level of < 10 g/dl. To avoid transfusions and to increase patients wellbeing, the efficacy and tolerability of erythropoietin was tested, when administered to increase the lowered hemoglobin levels in tumor patients. The question is, whether or not it is possible, to regularly raise the blood hemoglobin levels in patients with carcinoma of the cervix by administering erythropoietin. If a normal (>12 g/dl) or rather an upper-normal (>14 g/dl) hemoglobin level is reached, then the tumor oxygenation and thus also the response to radiation could be positively influenced. The objective of this study is to improve the response and control rates as well as the disease free survival rates in female patients with primary carcinoma of the cervix within the scope of the curative radiation therapy. The test hypothesis is that by administering erythropoietin the hemoglobin levels are increased and through this increase the response of the tumor to radiation therapy will be improved.
Comparison(s): A prospective, randomized, multi-centric group of female patients treated with Erythropoietin is compared to a parallel stratified control group receiving no treatment.
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
- 19 Years 至 80 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •histologically proven cervix cancer (FIGO stage I-IVA)
- •Age of 19-80 years
- •initial blood level of hemoglobin <= 14 g/dl
- •patients who gave their informed consent
排除标准
- •Karnofsky-Index < 50 %
- •known intolerance of erythropoietin
- •FIGO stage IVB
- •blood transfusion within the last four weeks
- •neoadjuvant chemotherapy
- •previous radiation therapy of the abdomen
研究组 & 干预措施
1
Patients assigned to this group are receiving Erythropoietin medication
干预措施: Erythropoietin (Drug)
结局指标
主要结局
remission rate 3 months after completion of the radiation therapy
时间窗: 3 months
local control rate
时间窗: 2 years
Disease specific survival
时间窗: 2 years
次要结局
- The extent of increase in hemoglobin levels during the treatment with erythropoietin.(Duration of treatment)
- The need of transfusion during the treatment.(Duration of treatment)
