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

NCT ID: NCT00348738

Last Updated: 2007-11-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-07-31
• Study Completion Date: 2009-07-31

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 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.

Conditions

Cervix Cancer

Keywords

radiotherapy; clinical trial; erythropoietin; cervix cancer; Phase III; 2 Arms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Patients assigned to this group are receiving Erythropoietin medication

Group Type: EXPERIMENTAL

Erythropoietin

Intervention Type: DRUG

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

control group receiving no treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Principal Investigators

Richard Poetter, Prof., M.D.

Role: STUDY_CHAIR

Department of Radiotherapy and Radiobiology-Medical University of Vienna

Locations

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, , Austria

Countries

Austria

References

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. doi: 10.1016/j.ygyno.2004.04.008.

Reference Type: BACKGROUND

PMID: 15297194 (View on PubMed)

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. doi: 10.1007/s00066-002-1081-x.

Reference Type: BACKGROUND

PMID: 12491062 (View on PubMed)

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. doi: 10.1016/s0167-8140(99)00139-5.

Reference Type: BACKGROUND

PMID: 10665785 (View on PubMed)

Other Identifiers

OEGRO54

Identifier Type: -

Identifier Source: org_study_id