Clinical trial NCT00348738: Impact of Erythropoietin Administration During Definitive Cervix Cancer Radiotherapy on Treatment Outcome
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cervix Cancer
Keywords: radiotherapy
clinical trial
erythropoietin
cervix cancer
Phase III
2 Arms
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2006-07-06
Enrollment: 300
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: remission rate 3 months after completion of the radiation therapy
timeFrame: 3 months
measure: local control rate
timeFrame: 2 years
measure: Disease specific survival
timeFrame: 2 years
Secondary outcomes:
measure: The extent of increase in hemoglobin levels during the treatment with erythropoietin.
timeFrame: Duration of treatment
measure: The need of transfusion during the treatment.
timeFrame: Duration of treatment
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Department of Radiotherapy-University Hospital of Innsbruck
city: Salzburg
country: Austria
facility: Department of Radiotherapy-University Hospital of Salzburg
city: Vienna
country: Austria
facility: Department of Radiotherapy and Radiobiology-Medical University of Vienna
city: Vienna
country: Austria
facility: Department of Radiotherapy-Hospital of Hietzing
Study officials:
affiliation: Department of Radiotherapy and Radiobiology-Medical University of Vienna
name: Richard Poetter, Prof., M.D.
role: STUDY_CHAIR
References:
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. doi: 10.1016/j.ygyno.2004.04.008.
citation: 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.
citation: 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.