No Surgery Trial / Two Dose-escalation Strategies

A Pilot Study of Two Dose Escalation Strategies to Increase the Population of Complete Responders After Radiation Therapy in Rectal Cancer Patients.

Ver estudio completo en Inglés
Patrocinadores

Patrocinador principal: Sir Mortimer B. Davis - Jewish General Hospital

Fuente Sir Mortimer B. Davis - Jewish General Hospital
Resumen breve

A randomized study of 40 patients. Patients with a clinical T2-3 N0 rectal cancer will be randomized to two arms (arm A: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy compared to arm B: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions).

Descripción detallada

It is becoming clear that there is a now an international consensus that rectal cancer research efforts need to be more focused in optimizing a non-surgical approach. This concept is very relevant to an ageing patient population with multiple co-morbidities regularly seen at the Jewish General Hospital and across the province. We are therefore proposing a pilot study of 40 patients to compare the two best known radiation dose escalation strategies and to achieve a complete clinical response. Patients with a clinical T2-3 N0-1 rectal cancer will be randomized to two arms (arm A: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy compared to arm B: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions). Patients that have a high risk of recurrence or with more advanced stages of the disease will be excluded from the study, as only the local disease is being treated. The primary outcome for this proposal is rectum preservation in treated patients.

Estado general Recruiting
Fecha de inicio April 25, 2017
Fecha de Terminación January 2022
Fecha de finalización primaria January 2021
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Rectum preservation in treated patients 2 years post treatment
Resultado secundario
Medida Periodo de tiempo
Local Recurrence 2 years post treatment
Disease-free survival 5 years post treatment
Overall survival 5 years post treatment
Overall Quality of life 5 years post treatment
Inscripción 40
Condición
  • Stage II Rectal Cancer
Intervención

Tipo de intervención: Procedure

Nombre de intervención: Complete responders and Non-complete responders

Descripción: Patients that are complete responders will not have surgery. Patients that are non-complete responders will have surgery.

Tipo de intervención: Radiation

Nombre de intervención: Chemoradiation + EBRT Boost

Descripción: 45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy in 5

Etiqueta de grupo de brazo: Chemoradiation + EBRT Boost

Tipo de intervención: Radiation

Nombre de intervención: Chemoradiation + HDRBT Boost

Descripción: 45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions

Etiqueta de grupo de brazo: Chemoradiation + HDRBT Boost

Elegibilidad

Criterios:

Inclusion Criteria:

- Rectal cancer patients, clinically staged as T2-T3 by MRI or endoscopic/trans-rectal ultrasound

- Rectal cancer staged as N0 by MRI or EUS/TRUS

- No metastatic lesion

- Rectal tumor occupying less than half of the circumference

- Tumor less than 5 cm on its largest dimension

- Tumor located at less than 10 cm from the anal verge

- Tumor penetration less than 5 mm in the mesorectal fat

- Tumor accessible for brachytherapy

- Lumen accessible for colonoscopy

- Patient should be a suitable candidate for brachytherapy and chemotherapy

- Older than 18 years of age

- Adequate birth control measures in women of childbearing potential

- Written informed consent

Exclusion Criteria:

- Patients with previous pelvic radiation

- Evidence of distant metastasis

- Extension of malignant disease to the anal canal

- Tumors staged as T4

- Tumors larger than 5 cm in length

Género: All

Edad mínima: 18 Years

Edad máxima: 80 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Te Vuong, MD Principal Investigator Sir Mortimer Jewish General Hospital
Contacto general

Apellido: Luciana Poggi, PhD

Teléfono: 514-340-8222

Teléfono Ext.: 28443

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Investigador: Jewish General Hospital Harielle Lamarre, BSc 514-340-8222 26199 [email protected] Te Vuong, MD Principal Investigator
Ubicacion Paises

Canada

Fecha de verificación

April 2020

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Sir Mortimer B. Davis - Jewish General Hospital

Nombre completo del investigador: Dr. Te Vuong

Título del investigador: Director, Radiation Oncology Department

Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Chemoradiation + EBRT Boost

Tipo: Experimental

Descripción: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy in 5; Complete responders and Non-complete responders

Etiqueta: Chemoradiation + HDRBT Boost

Tipo: Experimental

Descripción: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions; Complete responders and Non-complete responders

Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Source: ClinicalTrials.gov