Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00348738
Status:
UNKNOWN
Last Update Posted:
2007-11-02
First Post:
2006-07-05
Brief Title:
Impact of Erythropoietin Administration During Definitive Cervix Cancer Radiotherapy on Treatment Outcome
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2007-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 gdl 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 gdl or rather an upper-normal 14 gdl 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
Comparisons A prospective randomized multi-centric group of female patients treated with Erythropoietin is compared to a parallel stratified control group receiving no treatment
Comparisons A prospective randomized multi-centric group of female patients treated with Erythropoietin is compared to a parallel stratified control group receiving no treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None