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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Medical University of Vienna.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00348738
First received: July 5, 2006
Last updated: October 31, 2007
Last verified: October 2007
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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
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

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

Publications:
ClinicalTrials.gov Identifier: NCT00348738     History of Changes
Other Study ID Numbers: OEGRO54
Study First Received: July 5, 2006
Last Updated: October 31, 2007
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

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014