- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00069108
A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer
3 mars 2016 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
627
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Bruxelles, Belgien, 1070
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Bruxelles, Belgien, 1000
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Gent, Belgien, 9000
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Kortrijk, Belgien, 8500
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Mont-godinne, Belgien, 5530
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Tampere, Finland, 36280
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Turku, Finland, 20520
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Avignon, Frankrike, 84082
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Bordeaux, Frankrike, 33076
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Bordeaux, Frankrike, 33075
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Chambray-lès-tours, Frankrike, 37044
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Limoges, Frankrike, 87042
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Nimes, Frankrike, 30029
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Pessac, Frankrike, 33604
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Rouen, Frankrike, 76031
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California
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Bakersfield, California, Förenta staterna, 93309
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Colorado
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Colorado Springs, Colorado, Förenta staterna, 80903
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District of Columbia
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Washington, District of Columbia, Förenta staterna, 20007-2197
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Indiana
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Terre Haute, Indiana, Förenta staterna, 47802
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Missouri
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St Louis, Missouri, Förenta staterna, 63136
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Montana
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Billings, Montana, Förenta staterna, 59101
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New York
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Nyack, New York, Förenta staterna, 10960
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Texas
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Dallas, Texas, Förenta staterna, 75204
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Heraklion, Grekland, 71110
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Thessaloniki, Grekland, 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, Italien, 24128
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Cattolica, Italien, 47841
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Rimini, Italien, 47900
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Udine, Italien, 33100
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Alberta
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Edmonton, Alberta, Kanada, T6G 1Z2
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Kanada, A1B 3V6
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Nova Scotia
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Halifax, Nova Scotia, Kanada, B3H 1V7
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Ontario
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London, Ontario, Kanada, N6A 4L6
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Oshawa, Ontario, Kanada, L1G 2B9
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Ottawa, Ontario, Kanada, K1H 1C4
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Saint Catherines, Ontario, Kanada, L2R 2Z7
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Thunder Bay, Ontario, Kanada, P7A 7T1
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Toronto, Ontario, Kanada, M5G 2M9
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Weston, Ontario, Kanada, M9N 1N8
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Quebec
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Laval, Quebec, Kanada, H7M 3L9
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Levis, Quebec, Kanada, G6V 3Z1
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Montreal, Quebec, Kanada, H1T 2M4
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Montreal, Quebec, Kanada, H2W 1S6
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Montreal, Quebec, Kanada, H4J 1C5
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Quebec City, Quebec, Kanada, G1R 2J6
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Saskatchewan
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Regina, Saskatchewan, Kanada, S4T 7T1
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Buchun, Korea, Republiken av, 420-021
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Seoul, Korea, Republiken av, 138-736
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Seoul, Korea, Republiken av, 110-744
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Seoul, Korea, Republiken av, 120-752
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Seoul, Korea, Republiken av, 133-792
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Seoul, Korea, Republiken av, 137-040
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Split, Kroatien, 21000
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Zagreb, Kroatien, 10000
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Bialystok, Polen, 15-073
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Krakow, Polen, 31-501
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Warszawa, Polen, 02-781
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Warszawa, Polen, 04-394
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San Juan, Puerto Rico, 00921-3201
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Belgrade, Serbien, 11000
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Bratislava, Slovakien, 831 01
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Ljubljana, Slovenien, 1000
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Barcelona, Spanien, 08907
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Leganes, Spanien, 28911
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Madrid, Spanien, 28041
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Madrid, Spanien, 28035
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Palma de Mallorca, Spanien, 07014
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Denbigh, Storbritannien, LL18 5UJ
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Manchester, Storbritannien, M20 4BX
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Merseyside, Storbritannien, CH63 45Y
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Preston, Storbritannien, PR2 9HT
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Cape Town, Sydafrika, 7500
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Durban, Sydafrika, 4001
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Pietermaritzburg, Sydafrika, 3201
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Port Elizabeth, Sydafrika, 6001
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Pretoria, Sydafrika, 0001
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Kueishan, Taiwan
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Tainan, Taiwan, 704
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Taipei, Taiwan, 104
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Tübingen, Tyskland, 72076
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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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1000mg/m2 po-bud dag 1-15 i varje 3-veckorscykel
As prescribed, in 3 week cycles
As prescribed, in 2 week cycles
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Aktiv komparator: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Progression Free Survival
Tidsram: Up to 3 years
|
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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Progression Free Survival Based on Independent Review Committee Assessment
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Number of Participants With Marked Post-baseline Laboratory Abnormalities by Trial Treatment
Tidsram: Up to 3 years
|
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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2003
Primärt slutförande (Faktisk)
1 augusti 2006
Avslutad studie (Faktisk)
1 augusti 2006
Studieregistreringsdatum
Först inskickad
15 september 2003
Först inskickad som uppfyllde QC-kriterierna
17 september 2003
Första postat (Uppskatta)
18 september 2003
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
1 april 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 mars 2016
Senast verifierad
1 mars 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Neoplasmer
- Neoplasmer efter plats
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Gastrointestinala sjukdomar
- Kolonsjukdomar
- Tarmsjukdomar
- Intestinala neoplasmer
- Rektala sjukdomar
- Kolorektala neoplasmer
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Skyddsmedel
- Mikronäringsämnen
- Vitaminer
- Motgift
- Vitamin B-komplex
- Capecitabin
- Oxaliplatin
- Leucovorin
Andra studie-ID-nummer
- NO16967
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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