Impact of Erythropoietin Administration During Definitive Cervix Cancer Radiotherapy on Treatment Outcome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00348738
Recruitment Status : Unknown
Verified October 2007 by Medical University of Vienna.
Recruitment status was:  Active, not recruiting
First Posted : July 6, 2006
Last Update Posted : November 2, 2007
Information provided by:
Medical University of Vienna

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.

Condition or disease Intervention/treatment Phase
Cervix Cancer Drug: Erythropoietin Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2000
Estimated Study Completion Date : July 2009

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U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
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.
No Intervention: 2
control group receiving no treatment

Primary Outcome Measures :
  1. remission rate 3 months after completion of the radiation therapy [ Time Frame: 3 months ]
  2. local control rate [ Time Frame: 2 years ]
  3. Disease specific survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. The extent of increase in hemoglobin levels during the treatment with erythropoietin. [ Time Frame: Duration of treatment ]
  2. The need of transfusion during the treatment. [ Time Frame: Duration of treatment ]

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00348738

Department of Radiotherapy-University Hospital of Innsbruck
Innsbruck, Austria, A-6020
Department of Radiotherapy-University Hospital of Salzburg
Salzburg, Austria, A-5020
Department of Radiotherapy and Radiobiology-Medical University of Vienna
Vienna, Austria, A-1090
Department of Radiotherapy-Hospital of Hietzing
Vienna, Austria, A-1130
Sponsors and Collaborators
Medical University of Vienna
Study Chair: Richard Poetter, Prof., M.D. Department of Radiotherapy and Radiobiology-Medical University of Vienna

Publications: Identifier: NCT00348738     History of Changes
Other Study ID Numbers: OEGRO54
First Posted: July 6, 2006    Key Record Dates
Last Update Posted: November 2, 2007
Last Verified: October 2007

Keywords provided by Medical University of Vienna:
clinical trial
cervix cancer
Phase III
2 Arms

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Epoetin Alfa