- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00280761
Biomarkers in Patients With Rectal Cancer Undergoing Chemotherapy and Radiation Therapy
A Biologic Study of Global Gene Expression, NF-Kappa B and p53 in Adenocarcinoma of the Rectum.
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors understand how patients respond to treatment.
PURPOSE: This clinical trial is studying biomarkers in patients with rectal cancer undergoing chemotherapy and radiation therapy.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
Primary
- Observe whether NF-kappa B is activated in response to treatment with external beam radiotherapy.
- Correlate NF-kappa B pathway activation (presumed to be anti-apoptotic in nature) with therapeutic outcomes (as measured by rate of pathologic complete response or downstaging by endoscopic ultrasound [EUS]).
Secondary
- Study downstream events induced by NF-kappa B activation.
- Determine global gene expression profiles at baseline and during chemoradiotherapy.
- Correlate changes in gene expression (compared with the baseline gene expression pattern) induced by a single dose of external beam radiotherapy with patient outcomes (as measured by pathologic response rate or downstaging by EUS).
- Study downstream events related to activation of p53 in response to treatment with radiotherapy.
- Correlate p53 pathway-mediated events with clinical outcomes.
OUTLINE: Patients receive fluorouracil or capecitabine and undergo radiotherapy and surgery per standard care.
Patients undergo tumor pinch biopsies at baseline and on days 1 and 2 of chemoradiotherapy. At the time of final surgical resection, a portion of the remaining rectal tumor will be liquid nitrogen banked. Patients not deemed surgical candidates are evaluated by transrectal ultrasound 6-8 weeks after completion of chemoradiotherapy to assess ultrasound response (downstaging versus no downstaging).
Tumor tissue samples are analyzed for NF-kappa B pathway activation; downstream events induced by NF-kappa B activation; changes in global gene expression; p53 function; apoptosis; and mRNA expression. Laboratory techniques used include tissue microarray, ELISA, RNase protection assay, fluorescence semi-quantitative PCR, TUNEL, IHC, and cDNA microarray analysis.
If normal tissue from biopsies is not available, whole blood may be collected at any point while patient remains on study for correlative analysis or research related to rectal cancer.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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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
Descripción
DISEASE CHARACTERISTICS:
Must have rectal or sigmoid-rectal junction adenocarcinoma confirmed by sigmoidoscopy and pathologic diagnosis of biopsy sample
- Inferior margin of the tumor less than 15 cm from anal verge by rigid sigmoidoscopy or below the level of S1-2 at surgery
Candidate for chemotherapy and radiotherapy, as defined by any of the following:
- Tumor staged as T3 or N1-2 by rectal sonography
- Tumor occupying > 40% of circumference of rectum
- Tumor fixed to extra colonic structures as determined by digital rectal examination
- Tumor < 5 cm from sphincter mechanism
- Patient has inoperable disease and is being treated for palliation
- Pelvic or anastomotic recurrences of previously resected rectal cancer
- Planning to undergo chemotherapy and radiotherapy
- No sigmoid carcinoma (carcinoma proximal to the pelvic peritoneal reflection)
PATIENT CHARACTERISTICS:
- Not pregnant
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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1
Single Arm Trial
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Capecitabine administration (where deemed appropriate by the treating medical oncologist) will commence on the second day of radiotherapy after the 24-hour biopsy has been performed.
Dosing will be per current standard of care at the discretion of the treating Medical, Radiation and Surgical Oncologist
Otros nombres:
Administration of 5-fluorouracil (where deemed appropriate by the treating medical oncologist) will commence on the second day of radiotherapy after the 24-hour biopsy has been performed.
Dosing and dose modification will be per current standard of care at the discretion of the treating Medical, Radiation and Surgical Oncologist.
Otros nombres:
Surgery will occur approximately 2-6 weeks after chemoradiation depending on clinical factors (i.e.
resectability, presence or absence of metastatic disease).
Dosing and dose modification will be per current standard of care at the discretion of the treating Radiation Oncologist.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Activation of NF-kappa B in response to treatment with external beam radiotherapy
Periodo de tiempo: 6-8 weeks after chemoradiation
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6-8 weeks after chemoradiation
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Correlation of NF-kappa B pathway activation with therapeutic outcomes
Periodo de tiempo: 6-8 weeks after chemoradiation
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6-8 weeks after chemoradiation
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Downstream events induced by NF-kappa B activation
Periodo de tiempo: 12 months
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12 months
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Global gene expression profiles at baseline and during chemoradiotherapy
Periodo de tiempo: prior to chemoradiation and 72 days post chemoradiation
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prior to chemoradiation and 72 days post chemoradiation
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Correlation of changes in gene expression with patient outcomes
Periodo de tiempo: 72 days post chemoradiation
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72 days post chemoradiation
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Downstream events related to activation of p53 in response to treatment with radiotherapy
Periodo de tiempo: 72 post radiotherapy
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72 post radiotherapy
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Correlation of p53 pathway-mediated events with clinical outcomes
Periodo de tiempo: 72 days post chemoradiation
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72 days post chemoradiation
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Colaboradores e Investigadores
Patrocinador
Colaboradores
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 (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
- Enfermedades del Sistema Digestivo
- Neoplasias
- Neoplasias por sitio
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades Gastrointestinales
- Enfermedades del Colon
- Enfermedades intestinales
- Neoplasias Intestinales
- Enfermedades Rectales
- Neoplasias colorrectales
- Neoplasias Rectales
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Fluorouracilo
- Capecitabina
Otros números de identificación del estudio
- LCCC 0216
- P30CA016086 (Subvención/contrato del NIH de EE. UU.)
- CDR0000561688 (Otro identificador: PDQ number)
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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