- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00348738
Impact of Erythropoietin Administration During Definitive Cervix Cancer Radiotherapy on Treatment Outcome
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
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
-
-
-
Innsbruck, Østerrike, A-6020
- Department of Radiotherapy-University Hospital of Innsbruck
-
Salzburg, Østerrike, A-5020
- Department of Radiotherapy-University Hospital of Salzburg
-
Vienna, Østerrike, A-1090
- Department of Radiotherapy and Radiobiology-Medical University of Vienna
-
Vienna, Østerrike, A-1130
- Department of Radiotherapy-Hospital of Hietzing
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 1
Patients assigned to this group are receiving Erythropoietin medication
|
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.
|
Ingen inngripen: 2
control group receiving no treatment
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
lokal kontrollrate
Tidsramme: 2 år
|
2 år
|
remission rate 3 months after completion of the radiation therapy
Tidsramme: 3 months
|
3 months
|
Disease specific survival
Tidsramme: 2 years
|
2 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
The extent of increase in hemoglobin levels during the treatment with erythropoietin.
Tidsramme: Duration of treatment
|
Duration of treatment
|
The need of transfusion during the treatment.
Tidsramme: Duration of treatment
|
Duration of treatment
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Richard Poetter, Prof., M.D., Department of Radiotherapy and Radiobiology-Medical University of Vienna
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- OEGRO54
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