Cervix Cancer
Conditions
Keywords
radiotherapy, clinical trial, erythropoietin, cervix cancer, Phase III, 2 Arms
Brief summary
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
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.
Interventions
DRUGErythropoietin
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.
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Austria
Outcome results
None listed