Cervix CancerPhase 3NCT00348738
Impact of Erythropoietin Administration During Definitive Cervix Cancer Radiotherapy on Treatment Outcome
A Phase 3 study testing Erythropoietin in people with Cervix Cancer, run by Medical University of Vienna at 4 sites in Austria.
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. Read more about this study
- Who is it for?
- Ages 19 to 80 years, women only
- Conditions the study is for
- Cervix Cancer
- What is being tested?
- Erythropoietin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesAustria
- Study dates
- Jul 2000to Jul 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
Austria4 sites
Department of Radiotherapy-University Hospital of Innsbruck
Innsbruck, A-6020
Department of Radiotherapy-University Hospital of Salzburg
Salzburg, A-5020
Department of Radiotherapy and Radiobiology-Medical University of Vienna
Vienna, A-1090
Department of Radiotherapy-Hospital of Hietzing
Vienna, A-1130
About this study
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
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.
Read the 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
- Being tested
- Erythropoietin
- Keywords
- radiotherapy, clinical trial, erythropoietin, cervix cancer, Phase III, 2 Arms
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythropoietinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients assigned to this group are receiving Erythropoietin medication Receives: Drug: Erythropoietin |
| 2 | No intervention | control group receiving no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
remission rate 3 months after completion of the radiation therapy
Measured: 3 months
local control rate
Measured: 2 years
Disease specific survival
Measured: 2 years
Secondary outcomes (2)
The extent of increase in hemoglobin levels during the treatment with erythropoietin.
Measured: Duration of treatment
The need of transfusion during the treatment.
Measured: Duration of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2006 (estimated)
- Study startJul 2000
- Study completionJul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cervix CancerStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Richard Poetter, Prof., M.D., Study chair, Department of Radiotherapy and Radiobiology-Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348738
- Sponsor's protocol ID
- OEGRO54
- Status last verified
- Oct 2007
- First submitted
- 5 Jul 2006
- Last updated
- 2 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15297194Vaupel 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.
PubMed 12491062Knocke 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.
PubMed 10665785
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00348738
- Acronym / sponsor ID
- OEGRO54
- Conditions
- Cervix Cancer
- Keywords
- radiotherapy, clinical trial, erythropoietin, cervix cancer, Phase III, 2 Arms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jul 2000
- Study completion
- Jul 2009 (estimated)
- First posted
- 6 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ErythropoietinPatients assigned to this group are receiving Erythropoietin medication |
| 2 | No intervention | –control group receiving no treatment |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Karnofsky-Index < 50 %
- known intolerance of erythropoietin
- FIGO stage IVB
- blood transfusion within the last four weeks
- neoadjuvant chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErythropoietinAdministration 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. | Drug | 1 |
Primary outcome
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
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2007.
- Background: PubMed 15297194Winter 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.
- Background: PubMed 12491062Vaupel 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.
- Background: PubMed 10665785Knocke 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Poetter, Prof., M.D. study chair
Department of Radiotherapy and Radiobiology-Medical University of Vienna
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Erythropoietin in people with Cervix Cancer, run by Medical University of Vienna at 4 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
remission rate 3 months after completion of the radiation therapy (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00348738, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2007.