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

Medical University of Vienna

Status and phase: Unknown; Phase 3

Conditions: Cervix Cancer

Treatments: Drug: Erythropoietin

Study type: Interventional

Funder types: Other

Identifiers

NCT00348738

OEGRO54

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

1

Experimental group

Description:

Patients assigned to this group are receiving Erythropoietin medication

Treatment:

Drug: Erythropoietin

2

No Intervention group

Description:

control group receiving no treatment