Impact of Erythropoietin Administration During Definitive Cervix Cancer Radiotherapy on Treatment Outcome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Cervix Cancer

Intervention / Treatment
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* Drug: Erythropoietin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients assigned to this group are receiving Erythropoietin medication | Drug: Erythropoietin<br>* 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.<br>|
| No Intervention: 2<br>control group receiving no treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| remission rate 3 months after completion of the radiation therapy |  | 3 months | 
| local control rate |  | 2 years | 
| Disease specific survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiotherapy, clinical trial, erythropoietin, cervix cancer, Phase III, 2 Arms