- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00972881
Capecitabine, Irinotecan Hydrochloride, Cetuximab, and Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer (EXCITE)
EXCITE: Erbitux, Xeloda, Campto, Irradiation Then Excision for Locally Advanced Rectal Cancer (North West Clinical Oncology Group-04 on Behalf of the NCRI Rectal Cancer Subgroup)
RATIONALE: Drugs used in chemotherapy, such as capecitabine and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy, cetuximab, and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase I/II trial is studying the side effects of giving capecitabine and irinotecan hydrochloride together with cetuximab and radiation therapy and to see how well it works in treating patients undergoing surgery for locally advanced rectal cancer.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
OBJECTIVES:
- To assess the downstaging effectiveness and tolerability of neoadjuvant chemoradiotherapy comprising capecitabine, irinotecan hydrochloride, cetuximab, and radiotherapy in patients with locally advanced rectal cancer.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 1-2 hours once weekly in weeks 1-6 and irinotecan hydrochloride IV over 1 hour once weekly in weeks 2-5. Patients also undergo pelvic radiotherapy once daily and receive oral capecitabine twice daily on days 1-5 in weeks 2-6.
Patients undergo surgery 8 weeks after completion of chemoradiotherapy.
After completion of study treatment, patients are followed up at 6, 12, 24, and 36 months.
Peer Reviewed and Funded or Endorsed by Cancer Research United Kindom (UK).
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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England
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Leeds, England, Reino Unido, LS16 6QB
- Yorkshire Regional Clinical Trials & Research Unit
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Manchester, England, Reino Unido, M20 4BX
- Christie Hospital
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Merseyside, England, Reino Unido, CH63 4JY
- Clatterbridge Centre for Oncology
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Preston, England, Reino Unido, PR2 9HT
- Rosemere Cancer Centre at Royal Preston Hospital
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Wales
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Rhyl, Denbighshire, Wales, Reino Unido, LL 18 5UJ
- Cancer Research UK and University College London Cancer Trials Centre
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the rectum
MRI-defined locally advanced disease, as defined by 1 of the following:
- Mesorectal fascia involvement
- Mesorectal fascia threatened (tumor ≤ 1 mm from mesorectal fascia)
- Any T3 tumor < 5 cm from anal verge
- No evidence of metastatic disease
PATIENT CHARACTERISTICS:
- ECOG or WHO performance status 0-1
- ANC ≥ 1.5 x 10^9/L
- Platelet count ≥ 100 x 10^9/L
- Serum bilirubin < 1.25 times upper limit of normal (ULN)
- Serum transaminase(s) < 3 times ULN
- Serum alkaline phosphatase < 5 times ULN
- Estimated glomerular filtration rate > 50 mL/min
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Fit to receive all study treatments
- Able to comply with oral medication
- No comorbidity or coagulation problem that would deem the patient unsuitable for surgery
- No pre-existing condition that would preclude radiotherapy (e.g., fistulas, severe ulcerative colitis [particularly patients currently taking sulfasalazine], Crohn's disease, prior adhesions)
- No current or impending rectal obstruction (unless a defunctioning stoma is present) or metallic colonic rectal stent in situ
- No significant small bowel delineated within the radiotherapy fields
- No pelvic sepsis
- No gastrointestinal disorder that would interfere with oral therapy or oral bioavailability
- No uncontrolled cardiac, respiratory, or other disease that would preclude study therapy or informed consent
- No serious medical or psychiatric disorder that would preclude study therapy or informed consent
- No known dihydropyrimidine dehydrogenase deficiency
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy
- No prior radiotherapy to the pelvis
- No concurrent participation in other studies, except genetic studies (e.g., NSCCG-National Study of Colorectal Cancer Genetics)
- No concurrent St. John wort
- No other concurrent cytotoxic treatment or radiotherapy
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)
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Histologically confirmed R0 resection rate
Periodo de tiempo: Week 14 (6 weeks after treatment complete)
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Week 14 (6 weeks after treatment complete)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Radiotherapy compliance
Periodo de tiempo: Weeks 2, 3, 4, 5 & 6
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Radiotherapy treatment and dosage is captured on weekly CRFs from week 2-6
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Weeks 2, 3, 4, 5 & 6
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Grade 3 or 4 toxicity as assessed by NCI CTCAE v3.0
Periodo de tiempo: Baseline, week 1- 10, week 12 & 14 then at 6, 12, 24 & 36 months follow up
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Adverse events are recorded weekly on CRFs from week 1 of treatment until 4 weeks post treatment, then at 1 month post surgery and specified time points during long term follow up at 6, 12, 24 & 36 month intervals.
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Baseline, week 1- 10, week 12 & 14 then at 6, 12, 24 & 36 months follow up
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Pathological complete response
Periodo de tiempo: Week 14 (surgery conducted 6 weeks from end of treatment)
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Week 14 (surgery conducted 6 weeks from end of treatment)
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Post-operative morbidity
Periodo de tiempo: Week 14
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Week 14
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Long-term morbidity
Periodo de tiempo: Week 14, then at 6, 12, 24 & 36 months follow up
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Week 14, then at 6, 12, 24 & 36 months follow up
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Disease-free survival
Periodo de tiempo: Baseline, week 1- 10, week 12, 14 & then at 6, 12, 24 & 36 months follow up
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Baseline, week 1- 10, week 12, 14 & then at 6, 12, 24 & 36 months follow up
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Local failure-free survival
Periodo de tiempo: Baseline, weeks 1- 10, weeks 12 & 14 then at 6, 12, 24 & 36 months follow up
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Baseline, weeks 1- 10, weeks 12 & 14 then at 6, 12, 24 & 36 months follow up
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Simon Gollins, MD, Glan Clwyd Hospital
Publicaciones y enlaces útiles
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 intestinales
- Neoplasias Intestinales
- Enfermedades Rectales
- Neoplasias colorrectales
- Neoplasias Rectales
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Inhibidores de la topoisomerasa
- Agentes antineoplásicos inmunológicos
- Inhibidores de la topoisomerasa I
- Capecitabina
- Irinotecán
- Cetuximab
Otros números de identificación del estudio
- CDR0000648171
- CRUK-UCL-EXCITE
- EUDRACT-2007-006701-25
- EU-20964
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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-
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