Impact of Erythropoietin Administration During Definitive Cervix Cancer Radiotherapy on Treatment Outcome - Full Text View

Purpose

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.

Condition	Intervention	Phase
Cervix Cancer	Drug: Erythropoietin	Phase III

MedlinePlus related topics:

Cancer Cervical Cancer

ChemIDplus related topics:

Epoetin alfa Erythropoietin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:

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 Outcome Measures:

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 ]

Estimated Enrollment:	300
Study Start Date:	July 2000
Estimated Study Completion Date:	July 2009

Arms	Assigned Interventions
1: Experimental Patients assigned to this group are receiving Erythropoietin medication	Drug: 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.
2: No Intervention control group receiving no treatment

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.

Eligibility

Ages Eligible for Study:	19 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00348738

Locations


Austria
	Department of Radiotherapy and Radiobiology-Medical University of Vienna
	Vienna, Austria, A-1090
	Department of Radiotherapy-Hospital of Hietzing
	Vienna, Austria, A-1130
	Department of Radiotherapy-University Hospital of Salzburg
	Salzburg, Austria, A-5020
	Department of Radiotherapy-University Hospital of Innsbruck
	Innsbruck, Austria, A-6020

Sponsors and Collaborators

Medical University of Vienna

Investigators


Study Chair:	Richard Poetter, Prof., M.D.	Department of Radiotherapy and Radiobiology-Medical University of Vienna

More Information

Publications:

Winter WE 3rd, Maxwell GL, Tian C, Sobel E, Rose GS, Thomas G, Carlson JW. Association of hemoglobin level with survival in cervical carcinoma patients treated with concurrent cisplatin and radiotherapy: a Gynecologic Oncology Group Study. Gynecol Oncol. 2004 Aug;94(2):495-501.

Vaupel P, Thews O, Mayer A, Hockel S, Hockel M. Oxygenation status of gynecologic tumors: what is the optimal hemoglobin level? Strahlenther Onkol. 2002 Dec;178(12):727-31.

Knocke TH, Weitmann HD, Feldmann HJ, Selzer E, Potter R. Intratumoral pO2-measurements as predictive assay in the treatment of carcinoma of the uterine cervix. Radiother Oncol. 1999 Nov;53(2):99-104.

Study ID Numbers:	OEGRO54
First Received:	July 5, 2006
Last Updated:	October 31, 2007
ClinicalTrials.gov Identifier:	NCT00348738
Health Authority:	Austria: Federal Ministry for Health and Women

Keywords provided by Medical University of Vienna:

radiotherapy

clinical trial

erythropoietin

cervix cancer

Phase III

2 Arms

Study placed in the following topic categories:

Epoetin Alfa

Genital Diseases, Female

Uterine Cervical Neoplasms

Uterine Cervical Diseases

Genital Neoplasms, Female

Uterine Diseases

Uterine Neoplasms

Urogenital Neoplasms

Carcinoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Hematinics

Therapeutic Uses

Hematologic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 04, 2008

Sponsored by:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00348738