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

Cervix Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00348738
• Other study ID #: OEGRO54
• Status: Active, not recruiting
• Phase: Phase 3
• First received: July 5, 2006
• Last updated: October 31, 2007
• Start date: July 2000
• Est. completion date: July 2009

Study information

• Verified date: October 2007
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervix Cancer
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Austria	Department of Radiotherapy-University Hospital of Innsbruck	Innsbruck
Austria	Department of Radiotherapy-University Hospital of Salzburg	Salzburg
Austria	Department of Radiotherapy and Radiobiology-Medical University of Vienna	Vienna
Austria	Department of Radiotherapy-Hospital of Hietzing	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (3)

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

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	remission rate 3 months after completion of the radiation therapy		3 months
Primary	local control rate		2 years
Primary	Disease specific survival		2 years
Secondary	The extent of increase in hemoglobin levels during the treatment with erythropoietin.		Duration of treatment
Secondary	The need of transfusion during the treatment.		Duration of treatment