Sparing of Organs at Risk in High Dose Rate Brachytherapy
Prospective Study on the Sparing of Organs at Risk in High Dose Rate Brachytherapy for Cervix Cancer
Cervix carcinoma is a common malignancy. Radiation therapy still remains a major treatment for patients with carcinoma cervix. Conventional treatment with radiation therapy includes a combination of external beam radiation therapy and intracavitary treatment. Low dose rate intracavitary brachytherapy treatment is already well studied. But high dose rate brachytherapy is a relatively new alternative.
In brachytherapy, major developments have been made in the integration of 3D imaging and computerized 3D treatment planning. Medical imaging improvements allowed for better definition of tumoral volumes and organs at risk.
The GYN GEC-ESTRO published recommendations on the 3D imaging for better characterization of these volumes. Improvements in CT-SCan and lately in RMN had lead to a better definition of volums of interest (tumor and his extensions and organs at risk : bladder, rectum, sigmoidis, small bowels). RMN is the imaging standard in the evaluation of tumoral extension in cervix cancer. However its use is not easy in many brachytherapy departments.
This study will evaluate the feasibility and sparing of organs at risk for high dose rate brachytherapy if volume delineation is done at each of the two sessions performed with 3D RMN.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
After 60 Gy are delivered with Intensity Modulated Radiation Therapy (IMRT), the brachytherapy in high dose rate will deliver 15 Gy to the CTVhr (high risk CTV) in two sessions.
A clinical examination and an RMN are performed at the end of the external radiation to evaluate the residual tumoral volume. Two HDR brachytherapy sessions are then performed.
During the first session, a CT-Scan and an RMN will be performed after the fletcher application. A second CT-Scan will be performed during the second treatment session to create new volumes and to improve organs at risk sparing.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Lille, Francia, 59020
- Centre Oscar Lambret
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Patients with indication of HDR brachytherapy in cervix carcinoma of stage IB to II.
After realization of external radiation therapy done (60 Gy in IMRT)
Descripción
Inclusion Criteria:
- Cervix carcinoma stage Ib to IV (FIGO)
- OMS < 2
- Tomography by positron emission and/or chirurgical staging before the external radiotherapy
- RMN before the starting of treatment and at the end af external radiotherapy
- Patient information
- Validation of the indication af high dose rate brachytherapy
- External radiation therapy (60 Gy with IMRT)
Exclusion Criteria:
- No external radiation therapy
- Surgery in the 4 weeks before before the inclusion
- Prior pelvic radiation therapy
- intestinal inflammatory disease or active pathology
- active infection or severe pathology didn't allow the treatment
- Prior carcinoma in the last 5 years (except cutaneous carcinoma or in situ carcinoma)
- Inclusion in another clinical trial
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Evaluation of the sparing of organs at risk with a delineation at each session and the CTVhr volume modification
Periodo de tiempo: At 8 weeks of external radiotherapy
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To record the irradiated volumes modifications of each OAR at each session and the CTV volume modification.
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At 8 weeks of external radiotherapy
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Evaluation of medical imaging with CT-Scan and RMN for cervix cancer
Periodo de tiempo: At 8 weeks of external radiotherapy
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At 8 weeks of external radiotherapy
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Philippe Nickers, MD, PhD, Centre Oscar Lambret
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- BRACHY-HDR
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