- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00123318
A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
It has been shown recently in a study conducted in the USA (INT0116) that postoperative, adjuvant chemoradiotherapy improves survival for patients with gastric cancer. This treatment is relatively new and there remains debate regarding the optimal chemotherapy regimen and the optimal method of radiotherapy delivery. This study will evaluate a new regimen of adjuvant chemoradiotherapy for gastric cancer that employs ECF chemotherapy as the systemic component given before and after concurrent chemoradiation with continuous infusional 5-fluorouracil. Patients receive one cycle of ECF, followed 28 days later by chemoradiotherapy to a radiation dose of 45 Gy in 25 fractions over 5 weeks, and then one month later two further cycles of ECF are given. All patients are treated using multiple-field conformal radiation techniques.
The specific objectives of the study are:
- To detail the acute toxicity associated with this treatment.
- To determine the feasibility of the proposed concurrent chemoradiation regimen.
- To determine the feasibility of a standardized technique for radiation treatment planning and delivery.
The study will help to develop a common approach to the adjuvant treatment of gastric cancer, which is required before initiating further clinical trials in gastric cancer.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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New South Wales
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Liverpool, New South Wales, Australia, 1871
- Liverpool Hospital
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Newcastle, New South Wales, Australia, 2298
- Calvary Mater Newcastle
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Penrith, New South Wales, Australia, 2751
- Nepean Cancer Care Centre
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Randwick, New South Wales, Australia, 2031
- Prince of Wales Hospital
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Sydney, New South Wales, Australia, 2145
- Westmead Hospital
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Sydney, New South Wales, Australia, 2050
- Royal Prince Alfred Hospital
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Sydney, New South Wales, Australia, 2069
- Royal North Shore Hospital
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Queensland
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Brisbane, Queensland, Australia
- Mater QRI
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Herston, Queensland, Australia, 4029
- Royal Brisbane Hospital
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Tugun, Queensland, Australia, 4224
- East Coast Cancer Centre
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Woolloongabba, Queensland, Australia, 4102
- Princess Alexandra Hospital
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Tasmania
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Launceston, Tasmania, Australia, 7250
- Launceston General Hospital
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Victoria
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Box Hill, Victoria, Australia
- Box Hill Hospital
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Geelong, Victoria, Australia, 3220
- Andrew Love Cancer Care Centre, Geelong Hospital
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Melbourne, Victoria, Australia, 3081
- Austin Health
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Melbourne, Victoria, Australia, 8006
- Peter Maccallum Cancer Centre
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Prahran, Victoria, Australia, 3181
- Alfred Hospital
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Western Australia
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Perth, Western Australia, Australia, 6009
- Sir Charles Gairdner Hospital
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Christchurch, Nueva Zelanda, 4710
- Christchurch Hospital
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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:
All of the following must apply:
Histologically proven adenocarcinoma of the stomach or gastro-oesophageal junction that is:
- completely resected with negative margins
- Stage T3,4 and/or N1,2 patients who have undergone a D2 nodal dissection can be entered on the study at the discretion of the treating clinician.
- Age greater than or equal to 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2
Adequate organ function defined as follows:
- Bone marrow: Haemoglobin greater than or equal to 90 g/L; Neutrophil count greater than or equal to 1.5 x 10^9 /L; Platelet count greater than or equal to 100 x 10^9 /L
- Hepatic: Serum bilirubin less than or equal to 1.5 x ULN; AST and/or ALT less than or equal to 3.0 x ULN;
- Renal: Serum creatinine less than or equal to 0.150 mmol/L, and calculated creatinine clearance greater than or equal to 50mL/min.
- Adequate oral nutrition (intake greater than or equal to 1500 calories/day). This is to be assessed by a dietician prior to commencing treatment.
- Disease which can be radically treated to 45 Gy with standard fractionation.
- Patient able to be treated with infusional 5-fluorouracil (5-FU) and ECF chemotherapy.
- Written informed consent
Exclusion Criteria:
None of the following must apply:
- Evidence of metastatic disease.
- Prior chemotherapy or radiotherapy
- Patients with other significant underlying medical conditions that may be aggravated by the study treatment or are not controlled.
- Pregnant or lactating females or female patients of childbearing potential who have not been surgically sterilized or are without adequate contraceptive measures.
Cardiac failure (relevant to the use of epirubicin):
- Patients with myocardial infarction within the last 6 months;
- Patients with New York Heart Association class III/IV congestive heart failure
Plan de estudios
¿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 |
---|---|
Experimental: 1
Single-arm, non-randomised feasibility study to evaluate new regimen of adjuvant chemoradiotherapy (Epirubicin, Cisplatin, 5-Fluorouracil + radiotherapy)
|
50mg/m2 IV day 1
Otros nombres:
60mg/m2 IV day 1
Otros nombres:
5-FU 200mg/m2/d IV 21 day continuous infusion Cont.
infusional 5-FU 225mg/m2/day, 7 days/wk throughout entire period RT via CADD pump through PICC line
Otros nombres:
45Gy 25 Fractions, 5 days/week for 5 weeks
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
The percentage of patients who develop grade 3 or grade 4 haematological and gastrointestinal acute toxicity
Periodo de tiempo: Final analysis will be at 3 years.
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Final analysis will be at 3 years.
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The percentage of patients who complete the planned chemoradiation protocol
Periodo de tiempo: Final analysis will be at 3 years.
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Final analysis will be at 3 years.
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The percentage of major radiotherapy protocol violations
Periodo de tiempo: Final analysis will be at 3 years.
|
Final analysis will be at 3 years.
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Median survival and overall survival at 3 years
Periodo de tiempo: 3 years
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3 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Trevor Leong, Peter MacCallum Cancer Centre, Australia
Publicaciones y enlaces útiles
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
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Neoplasias
- Neoplasias por sitio
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades Gastrointestinales
- Enfermedades del Estómago
- Neoplasias de Estómago
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Inhibidores de la topoisomerasa II
- Inhibidores de la topoisomerasa
- Antibióticos, Antineoplásicos
- Cisplatino
- Fluorouracilo
- Epirubicina
Otros números de identificación del estudio
- TROG 03.02
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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