Overview

This trial is active, not recruiting.

Condition cervix cancer
Treatment erythropoietin
Phase phase 3
Sponsor Medical University of Vienna
Start date July 2000
End date July 2009
Trial size 300 participants
Trial identifier NCT00348738, OEGRO54

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients assigned to this group are receiving Erythropoietin medication
erythropoietin
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)
control group receiving no treatment

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Female participants from 19 years up to 80 years old.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2007.
Information provided to ClinicalTrials.gov by Medical University of Vienna.