Trial Information

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

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.