Phase III Study Comparing 3D Conformal Radiotherapy and Conformal Radiotherapy IMRT to Treat Endometrial Cancer (TOMOGYN)
Phase III Study Comparing 3D Conformal Radiotherapy and Conformal Radiotherapy IMRT to Treat Endometrial Cancer of 70 Years Old Women : Contribution of Oncogeriatric Evaluation to the Study of Acute Toxicity
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Endometrial cancer is the most common form of gynecological cancer in France with 6560 new cases in 2010. Endometrial cancers occurs generally after menopause but are sometimes diagnosticated before 40 years. The 5 years Overall survival of endometrial cancer is 76% (95% for non locally advanced or non metastatic disease).
Some factors are involved in disease prognostic: age, geographical origin, physical status, tumor grade, tumor histology and probably biomarkers. Some studies demonstrated that advanced age is a negative prognostic factor due to higher relapse risk and higher specific mortality. Unfortunately, Incidence of endometrial cancer will probably increase in future due to aging of the occidental population.
Current treatment of endometrial cancer is based on post-operative radiation therapy: adjuvant brachytherapy or adjuvant external beam radiation therapy. However these techniques lead to serious toxicity (digestive toxicity, ileitis...) in elder patient. Consequently, pelvic radiation therapy is difficult to organize before 75 years and dangerous to perform after 80 years.
However a new technique called: Intensity-modulated radiation therapy (IMRT) can make the difference. IMRT is a new high precision radiotherapy technique probably well adapted for old people, with less toxicity than current radiotherapy.
Nevertheless, IMRT is not recognized as a standard radiation therapy procedure in France and Europe.
Thus, goal of TOMOGYN study is to compare the tolerance of old women (at least 70 years), with endometrial cancer, treated with external beam radiation therapy or IMRT.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Bordeaux, Francia, 33076
- Bergonié Institut
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Caen, Francia, 14076
- François Baclesse Center
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Lille, Francia, 59020
- Oscar Lambret Center
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Lyon, Francia, 69373
- Centre Leon Berard
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Reims, Francia, 51726
- Institut Jean Godinot
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Saint Herblain, Francia, 44805
- René Gauducheau Center
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Strasbourg, Francia, 67065
- Paul Strauss Center
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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:
- endometrial adenocarcinoma histologically proven
- post op pelvic radiotherapy
- age ≥ 70
- performance status ≤ 2
- MMSE ≥ 10
- life expectancy ≥ 3 months
- social security covered
- signed informed consent
Exclusion Criteria:
- type I stade IAGI and stade IAGIII without myometer infiltration, stade IIIc2 and IV adenocarcinoma
- uterine sarcoma
- surgery not in accordance with recommendations of Inca
- previous uncontrolled or less than 5 years prior to diagnosis cancer
- cons-indication for radiotherapy
- diarrhea ≥ 3 per day
- pelvic lymph nodes > 1cm not resected during staging
- previous sigmoid diverticulitis, crohn disease, systemic disease, ulcerative haemorrhagic, collagenosis, infectious peritonitis
- IMRT other than tomotherapy
- photon energy < 10MV
- patient under guardianship
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 3D conformational radiotherapy
25 * 1.8 Gy in 5 weeks (=45 Gy).
3D conformational radiation
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25 * 1.8 Gy in 5 weeks (=45 Gy)
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Experimental: Intensity-Modulated Radiation Therapy
25 * 1.8 Gy in 5 weeks (=45 Gy).
IMRT
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25 * 1.8 Gy in 5 weeks (=45 Gy)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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change from baseline in acute toxicity all along the radiation
Periodo de tiempo: baseline, Day 5, Day 10, Day 15, Day 20, Day 25, 1 Week after end of treatment, 8 Weeks after end of treatment
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NCI CTCAE v 4.0 tox > grade 2 will be compared
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baseline, Day 5, Day 10, Day 15, Day 20, Day 25, 1 Week after end of treatment, 8 Weeks after end of treatment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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geriatric intervention
Periodo de tiempo: up to 6 months
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number of intervention, consequences in terms of base treatment change, intervention of other specialists (except cancer)
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up to 6 months
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geriatric repercussion
Periodo de tiempo: baseline, 6 months after end of treatment
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scales : Activities in Daily Living (ADL), Instrumental Activities in Daily Living (IADL), Mini Nutritionnal Assessment (MNA), Geriatric Depression Scale (GDS), cognitive evaluation, Cumulative Illness RAting Scale-Geriatrics (CIRS-G), sociocultural questionnaire, walking and balance
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baseline, 6 months after end of treatment
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duration of the radiation
Periodo de tiempo: up to 5 weeks and a half
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interval between first day and last day of treatment
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up to 5 weeks and a half
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quality of life
Periodo de tiempo: baseline, Day 5, Day 10, Day 15, Day 20, Day 25, 1 week and 8 weeks after end of treatment, 6, 12, 18 and 24 months after end of treatment
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QLQ C30 questionnaire
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baseline, Day 5, Day 10, Day 15, Day 20, Day 25, 1 week and 8 weeks after end of treatment, 6, 12, 18 and 24 months after end of treatment
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late major toxicity
Periodo de tiempo: 1 week, 8 weeks, 6, 12, 18 and 24 months after the end of treatment
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NCI CTCAE v 4.0
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1 week, 8 weeks, 6, 12, 18 and 24 months after the end of treatment
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progression free survival
Periodo de tiempo: an average period of 2 years
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median time between date of inclusion and date of clinical or radialogical progression
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an average period of 2 years
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Le Tinier Florence, MD, Centre Oscar Lambret
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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 (Actual)
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
- TOMOGYN - 1105
- 2011-A01543-38 (Otro identificador: DEDIM (ANSM))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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