Concurrent Chemoradiation With Concomitant Boost In Locally Advanced Rectal Cancer
29 de marzo de 2016 actualizado por: Lorenzo Fuccio, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Concurrent Chemoradiation With Concomitant Boost In Locally Advanced Rectal Cancer: A Phase II Study.
Neoadjuvant chemoradiation (CRT), is considered the standard treatment of locally advanced rectal cancer with a positive impact on locoregional control and survival.However, patients with T4 rectal cancer show high risk of local recurrence after conventional treatment.
Therefore investigators designed a prospective Phase II study on patients with locally advanced rectal cancer or locally recurrences, to evaluate the efficacy in terms of pathological response and resectability of concomitant boost RT (55 Gy/5 weeks) with concurrent Raltitrexed and Oxaliplatin (Tom-Ox) chemotherapy.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Neoadjuvant chemoradiation (CRT), is considered the standard treatment of locally advanced rectal cancer with a positive impact on locoregional control and survival.
However, patients with T4 rectal cancer show high risk of local recurrence (LR) after conventional treatment.
This was a prospective Phase II study on patients with locally advanced rectal cancer or locally recurrences, to evaluate the efficacy in terms of pathological response and resectability of concomitant boost RT (55 Gy/5 weeks) with concurrent Raltitrexed and Oxaliplatin (Tom-Ox) chemotherapy.
The primary aim was to assess the pathological complete response rate.
Key secondary aim was the resectability.
Secondary aims were evaluation of treatment-related acute and late toxicity, local control, disease-free survival and overall survival (OS).
The follow-up period of each subjects started after the radiochemotherapy treatment and ended after a maximum of 36 months of observation or until death.
Tipo de estudio
Intervencionista
Inscripción (Actual)
18
Fase
- Fase 2
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Histologically proven locally advanced (T4N0-2) or locally recurrent rectal adenocarcinoma;
- Age ≥ 18 years;
- Eastern Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Exclusion Criteria:
- Metastatic patients
- unfit surgery patients,
- pregnant or breast feeding females
- patients with clinically detectable ascites
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Radiotherapy plus Tom-Ox
Patients received concomitant boost RT (55 Gy/5 weeks) with concurrent Tom-Ox chemotherapy.
The concurrent chemotherapy consisted of 15 min intravenous infusion Raltitrexed (Tomudex ®) 3 mg/m2 and a two-hours intravenous infusion of Oxaliplatin (Eloxatin ®) at 130 mg/m 2, 20 min after raltitrexed, on days 1, 17, 35.
|
Radiotherapy was applied as conformal 3-D technique and was delivered with photon energies of 10 - 15 MV.
The beams were delivered by an Elekta Precise Linac equipped with standard multi leaf collimators (MLC).
A daily online check of isocenter position was performed using portal imaging, with set-up correction in case of displacement > 0.5 cm in any direction.
Radiation dose delivered to PTV2 was 45 Gy (1.8 Gy/fraction) with a concomitant boost dose to the PTV1 of 10 Gy with accelerated fractionation at 2.2 Gy/fraction, five consecutive days for week.
The concurrent chemotherapy consisted of 15 min intravenous infusion Raltitrexed (Tomudex ®) 3 mg/m2 and a two-hours intravenous infusion of Oxaliplatin (Eloxatin ®) at 130 mg/m 2, 20 min after raltitrexed, on days 1, 17, 35.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of patients defined as good responders (G1 or G2) according to the Mandard regression grading system.
Periodo de tiempo: 8 weeks after chemo-radiotherapy
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Pathologic responses of the primary tumours were defined according to the Mandard regression grading system: grade 1 was recorded when no tumour cells remained in the primary tumour and lymph nodes (pCR); grade 2 was characterized by the presence of rare residual cancer cells scattered through the fibrosis; grade 3 was characterized by an increase in the number of residual cancer cells, but fibrosis still predominated; grade 4 showed residual cancer outgrowing fibrosis; and grade 5 was characterized by an absence of regressive changes.
Good responders were defined those patients with a pathologic response with Mandard G1 or G2 and poor responder patients with Mandard G3, G4 or G5.
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8 weeks after chemo-radiotherapy
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of patients in which a surgical resection was feasible
Periodo de tiempo: 8 weeks after chemo-radiotherapy
|
8 weeks after chemo-radiotherapy
|
|
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Number of participants with treatment-related adverse events as assessed by CTCAE v3.0
Periodo de tiempo: Up to 36 months. In details, follow-up examinations were performed 4 weeks after surgery and every 6 months until the established length of follow-up or death.
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CTCAE v 3.0 was used to score acute and late radiation toxicity.
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Up to 36 months. In details, follow-up examinations were performed 4 weeks after surgery and every 6 months until the established length of follow-up or death.
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The number of patients without disease (i.e. rectal cancer) during the follow-up.
Periodo de tiempo: Up to 36 months.
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The disease-free survival (DFS) was defined as the time from the diagnosis to the documented local or distant recurrence or last follow-up.
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Up to 36 months.
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The number of patients still alive at the end of follow-up
Periodo de tiempo: Up to 36 months
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The overall-survival (OS) was defined as the time from the diagnosis until death for any cause or the last follow-up.
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Up to 36 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Alessio G Morganti, Prof, Division of Radiation Oncology, S.Orsola-Malpighi Hospital, Bologna, Italy
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de enero de 2005
Finalización primaria (Actual)
1 de enero de 2008
Finalización del estudio (Actual)
1 de febrero de 2012
Fechas de registro del estudio
Enviado por primera vez
19 de marzo de 2016
Primero enviado que cumplió con los criterios de control de calidad
29 de marzo de 2016
Publicado por primera vez (Estimar)
30 de marzo de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
30 de marzo de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
29 de marzo de 2016
Última verificación
1 de marzo de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Neoplasias
- Neoplasias por sitio
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades Gastrointestinales
- Enfermedades intestinales
- Neoplasias Intestinales
- Enfermedades Rectales
- Neoplasias colorrectales
- Neoplasias Rectales
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Antagonistas del ácido fólico
- Raltitrexed
Otros números de identificación del estudio
- TOMOX Rectal Study
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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