- ICH GCP
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- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Innsbruck, Austria, A-6020
- Department of Radiotherapy-University Hospital of Innsbruck
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Salzburg, Austria, A-5020
- Department of Radiotherapy-University Hospital of Salzburg
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Vienna, Austria, A-1090
- Department of Radiotherapy and Radiobiology-Medical University of Vienna
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Vienna, Austria, A-1130
- Department of Radiotherapy-Hospital of Hietzing
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 1
Patients assigned to this group are receiving Erythropoietin medication
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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.
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Sin intervención: 2
control group receiving no treatment
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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tasa de control local
Periodo de tiempo: 2 años
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2 años
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remission rate 3 months after completion of the radiation therapy
Periodo de tiempo: 3 months
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3 months
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Disease specific survival
Periodo de tiempo: 2 years
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2 years
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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The extent of increase in hemoglobin levels during the treatment with erythropoietin.
Periodo de tiempo: Duration of treatment
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Duration of treatment
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The need of transfusion during the treatment.
Periodo de tiempo: Duration of treatment
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Duration of treatment
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Richard Poetter, Prof., M.D., Department of Radiotherapy and Radiobiology-Medical University of Vienna
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- OEGRO54
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