Impact of Erythropoietin Administration During Definitive Cervix Cancer Radiotherapy on Treatment Outcome
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|ClinicalTrials.gov Identifier: NCT00348738|
Recruitment Status : Unknown
Verified October 2007 by Medical University of Vienna.
Recruitment status was: Active, not recruiting
First Posted : July 6, 2006
Last Update Posted : November 2, 2007
|Condition or disease||Intervention/treatment||Phase|
|Cervix Cancer||Drug: Erythropoietin||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||July 2000|
|Estimated Study Completion Date :||July 2009|
Patients assigned to this group are receiving Erythropoietin medication
Administration of 10.000 I.U Erythropoeitin SQ 3x/week, two weeks prior to radiation therapy until a haemoglobin concentration of >14g/dl, <15g/dl is reached or until the end of the radiation therapy.
No Intervention: 2
control group receiving no treatment
- remission rate 3 months after completion of the radiation therapy [ Time Frame: 3 months ]
- local control rate [ Time Frame: 2 years ]
- Disease specific survival [ Time Frame: 2 years ]
- The extent of increase in hemoglobin levels during the treatment with erythropoietin. [ Time Frame: Duration of treatment ]
- The need of transfusion during the treatment. [ Time Frame: Duration of treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00348738
|Department of Radiotherapy-University Hospital of Innsbruck|
|Innsbruck, Austria, A-6020|
|Department of Radiotherapy-University Hospital of Salzburg|
|Salzburg, Austria, A-5020|
|Department of Radiotherapy and Radiobiology-Medical University of Vienna|
|Vienna, Austria, A-1090|
|Department of Radiotherapy-Hospital of Hietzing|
|Vienna, Austria, A-1130|
|Study Chair:||Richard Poetter, Prof., M.D.||Department of Radiotherapy and Radiobiology-Medical University of Vienna|