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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00069108
A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer
3 de marzo de 2016 actualizado por: Hoffmann-La Roche
An Open-Label Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) ("XELOX") Versus Bolus and Continuous Infusion Fluorouracil/ Intravenous Leucovorin With Intravenous Oxaliplatin (Q2W) ("FOLFOX4") as Treatment for Patients With Metastatic Colorectal Cancer Who Have Received Prior Treatment With CPT-11 in Combination With 5-FU/LV as First Line Therapy
This 2 arm study will assess the efficacy and safety of intermittent oral Xeloda, or iv fluorouracil/leucovorin, in combination with intravenous Eloxatin (oxaliplatin) in patients previously treated for metastatic colorectal cancer.
Patients will be randomized to receive either 1)XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2) FOLFOX-4 (oxaliplatin + leucovorin + 5-FU in 2 week cycles.
The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
627
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Tübingen, Alemania, 72076
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Bruxelles, Bélgica, 1070
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Bruxelles, Bélgica, 1000
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Gent, Bélgica, 9000
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Kortrijk, Bélgica, 8500
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Mont-godinne, Bélgica, 5530
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Alberta
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Edmonton, Alberta, Canadá, T6G 1Z2
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canadá, A1B 3V6
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Nova Scotia
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Halifax, Nova Scotia, Canadá, B3H 1V7
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Ontario
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London, Ontario, Canadá, N6A 4L6
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Oshawa, Ontario, Canadá, L1G 2B9
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Ottawa, Ontario, Canadá, K1H 1C4
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Saint Catherines, Ontario, Canadá, L2R 2Z7
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Thunder Bay, Ontario, Canadá, P7A 7T1
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Toronto, Ontario, Canadá, M5G 2M9
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Weston, Ontario, Canadá, M9N 1N8
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Quebec
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Laval, Quebec, Canadá, H7M 3L9
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Levis, Quebec, Canadá, G6V 3Z1
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Montreal, Quebec, Canadá, H1T 2M4
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Montreal, Quebec, Canadá, H2W 1S6
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Montreal, Quebec, Canadá, H4J 1C5
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Quebec City, Quebec, Canadá, G1R 2J6
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Saskatchewan
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Regina, Saskatchewan, Canadá, S4T 7T1
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Buchun, Corea, república de, 420-021
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Seoul, Corea, república de, 138-736
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Seoul, Corea, república de, 110-744
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Seoul, Corea, república de, 120-752
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Seoul, Corea, república de, 133-792
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Seoul, Corea, república de, 137-040
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Split, Croacia, 21000
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Zagreb, Croacia, 10000
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Bratislava, Eslovaquia, 831 01
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Ljubljana, Eslovenia, 1000
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Barcelona, España, 08907
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Leganes, España, 28911
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Madrid, España, 28041
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Madrid, España, 28035
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Palma de Mallorca, España, 07014
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California
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Bakersfield, California, Estados Unidos, 93309
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Colorado
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Colorado Springs, Colorado, Estados Unidos, 80903
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20007-2197
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Indiana
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Terre Haute, Indiana, Estados Unidos, 47802
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Missouri
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St Louis, Missouri, Estados Unidos, 63136
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Montana
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Billings, Montana, Estados Unidos, 59101
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New York
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Nyack, New York, Estados Unidos, 10960
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Texas
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Dallas, Texas, Estados Unidos, 75204
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Tampere, Finlandia, 36280
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Turku, Finlandia, 20520
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Avignon, Francia, 84082
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Bordeaux, Francia, 33076
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Bordeaux, Francia, 33075
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Chambray-lès-tours, Francia, 37044
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Limoges, Francia, 87042
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Nimes, Francia, 30029
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Pessac, Francia, 33604
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Rouen, Francia, 76031
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Heraklion, Grecia, 71110
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Thessaloniki, Grecia, 56439
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Beer Sheva, Israel, 8410101
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Jerusalem, Israel, 91031
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Kfar Saba, Israel, 44281
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Petach Tikva, Israel, 49100
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Ramat-gan, Israel, 52621
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Rehovot, Israel, 76100
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Tel Aviv, Israel, 6423906
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Bergamo, Italia, 24128
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Cattolica, Italia, 47841
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Rimini, Italia, 47900
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Udine, Italia, 33100
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Bialystok, Polonia, 15-073
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Krakow, Polonia, 31-501
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Warszawa, Polonia, 02-781
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Warszawa, Polonia, 04-394
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San Juan, Puerto Rico, 00921-3201
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Denbigh, Reino Unido, LL18 5UJ
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Manchester, Reino Unido, M20 4BX
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Merseyside, Reino Unido, CH63 45Y
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Preston, Reino Unido, PR2 9HT
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Belgrade, Serbia, 11000
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Cape Town, Sudáfrica, 7500
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Durban, Sudáfrica, 4001
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Pietermaritzburg, Sudáfrica, 3201
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Port Elizabeth, Sudáfrica, 6001
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Pretoria, Sudáfrica, 0001
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Kueishan, Taiwán
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Tainan, Taiwán, 704
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Taipei, Taiwán, 104
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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:
- adult patients >=18 years of age;
- metastatic colorectal cancer;
- >=1 target lesion;
- failed first-line chemotherapy with 5-fluorouracil and irinotecan.
Exclusion Criteria:
- previous treatment with oxaliplatin;
- progressive or recurrent disease during or within 6 months of completion of first-line chemotherapy;
- >=1 previous chemotherapeutic agent or systemic anticancer regimen for metastatic disease.
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: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: XELOX
Participants received XELOX (oxaliplatin and capecitabine).
Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine.
Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
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1000 mg/m2 po bid en los días 1-15 de cada ciclo de 3 semanas
As prescribed, in 3 week cycles
As prescribed, in 2 week cycles
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Comparador activo: FOLFOX-4
Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination).
Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m^2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours.
On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours.
It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
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As prescribed, in 3 week cycles
As prescribed, in 2 week cycles
As prescribed, in 2 week cycles
As prescribed, in 2 week cycles
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Progression Free Survival
Periodo de tiempo: Up to 3 years
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Progression free survival (PFS) is defined as the time from the date of randomization to the day of documented disease progression or death from any cause.
It was based on tumor assessments made according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0, wherein progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter (LD) of the target lesions (TLs), taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-target lesions.
Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed.
Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization
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Up to 3 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Progression Free Survival Based on Independent Review Committee Assessment
Periodo de tiempo: Up to 3 years
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Progression free survival (PFS) is defined as the time from the date of randomization to the day of documented disease progression or death from any cause.
It was based on tumor assessments made according to the RECIST version 1.0, wherein PD was defined as at least a 20% increase in the sum of the LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-TLs.
Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed.
Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization.
This PFS evaluation was based on Independent Review Committee Assessment.
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Up to 3 years
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Progression Free Survival Based on Treatment Analysis- Intent To Treat Population
Periodo de tiempo: Up to 3 years
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Progression free survival (PFS) is defined as the time from date of randomization to day of documented disease progression or death from any cause.
It was based on tumor assessments made according to the RECIST version 1.0, wherein PD was defined as at least a 20% increase in the sum of LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-TLs.
Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed.
Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization.
PFS was analyzed using an on-treatment approach included only disease progression and death that occurred no later than 28 days after the last confirmed intake of study medication in the primary study treatment phase.
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Up to 3 years
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Progression Free Survival Based on Treatment Analysis- Per Population
Periodo de tiempo: Up to 3 years
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Progression free survival (PFS) is defined as the time from the date of randomization to the day of documented disease progression or death from any cause.
It was based on tumor assessments made according to the RECIST version 1.0, wherein PD was defined as at least a 20% increase in the sum of the LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-TLs.
Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed.
Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization
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Up to 3 years
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Best Overall Response, Investigators' Assessments
Periodo de tiempo: Up to 3 years
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Best overall response is best response recorded from start of treatment until disease progression/recurrence where responses include complete response (CR), partial response (PR), or stable disease (SD).
CR was defined as disappearance of all TLs, non-TLs along with normalization of tumor marker level.
PR is at least 30% decrease in sum of the LD of TLs, taking as reference baseline sum LD.
SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking reference of smallest sum LD since treatment started.
It was dependent on achievement of measurement and confirmation criteria.
BOR .i.e.
CR or PR was confirmed by repeat assessments performed within 4 weeks.
For SD, follow-up assessments had to meet the SD criteria at least once after study entry within 6 to 8 weeks.
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Up to 3 years
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Best Overall Response, Independent Review Committee Assessment
Periodo de tiempo: Up to 3 years
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Best overall response is best response recorded from start of treatment until disease progression/recurrence where responses include CR, PR, or SD.
CR was defined as disappearance of all TLs, non-TLs along with normalization of tumor marker level.
PR is at least 30% decrease in sum of the LD of TLs, taking as reference baseline sum LD.
SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking reference of smallest sum LD since treatment started.
It was dependent on achievement of measurement and confirmation criteria.
BOR .i.e.
CR or PR was confirmed by repeat assessments performed within 4 weeks, for SD, follow-up assessments had to meet the SD criteria at least once after study entry within 6 to 8 weeks.
This PFS evaluation was based on Independent Review Committee Assessment.
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Up to 3 years
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Overall Survival
Periodo de tiempo: Up to 3 years
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Overall survival was measured as the time from the date of randomization to the date of death.
Participant who were not reported to have died at the time of the analysis were censored using the date they were last known to be alive.
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Up to 3 years
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Time To Response
Periodo de tiempo: Up to 3 years
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Time to response (TOR) (best response of CR or PR) was measured as the time from randomization to the first date on which the measurement criteria for CR or PR (whichever status was recorded first) were met.
CR for TLs was defined as disappearance of all TLs and for non-TLs as disappearance of all non-TLs and normalization of tumor marker level.
PR was defined as at least 30% decrease in the sum of the LD of TLs, taking as reference the baseline sum LD.
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Up to 3 years
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Duration Of Response
Periodo de tiempo: Up to 3 years
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Duration of response (DOR) is defined as the time when CR or PR was first met up to first date that PD or death is documented.
CR is defined as disappearance of all TLs and non TLs, PR is defined as at least 30% decrease in the sum of the LD of TLs, taking as reference the baseline sum LD.
PD was defined as at least a 20% increase in the sum of the LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions for the TLs or the appearance of one or more new lesions and/or unequivocal progression of existing non-TLs.
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Up to 3 years
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Time To Treatment Failure
Periodo de tiempo: Up to 3 years
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Time to treatment failure was defined as the time from the date of randomization to the first occurrence of adverse event (AE), insufficient therapeutic response, death, failure to return, or refusing treatment/being uncooperative/withdrawing consent.
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Up to 3 years
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Number of Participants With Marked Post-baseline Laboratory Abnormalities by Trial Treatment
Periodo de tiempo: Up to 3 years
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Laboratory abnormalities were defined as those values that were outside the Roche defined reference range and showed a clinically relevant change from baseline.
All laboratory parameters were categorized according to the National Cancer Center Common Toxicity Criteria (NCI-CTCAE) grading system.
Incidence of Grade 1 to 4 laboratory abnormalities are presented in the table below.
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Up to 3 years
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 julio de 2003
Finalización primaria (Actual)
1 de agosto de 2006
Finalización del estudio (Actual)
1 de agosto de 2006
Fechas de registro del estudio
Enviado por primera vez
15 de septiembre de 2003
Primero enviado que cumplió con los criterios de control de calidad
17 de septiembre de 2003
Publicado por primera vez (Estimar)
18 de septiembre de 2003
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
1 de abril de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
3 de marzo de 2016
Última verificación
1 de marzo de 2016
Más información
Términos relacionados con este estudio
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
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Agentes Protectores
- Micronutrientes
- Vitaminas
- Antídotos
- Complejo de vitamina B
- Capecitabina
- Oxaliplatino
- Leucovorina
Otros números de identificación del estudio
- NO16967
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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