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临床试验/NCT00348738
NCT00348738Unknown3 期

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

Medical University of Vienna4 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2000年7月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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)

研究者

申办方类型
Other

研究点 (4)

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