- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00069108
A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer
3. března 2016 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
627
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
-
Bruxelles, Belgie, 1070
-
Bruxelles, Belgie, 1000
-
Gent, Belgie, 9000
-
Kortrijk, Belgie, 8500
-
Mont-godinne, Belgie, 5530
-
-
-
-
-
Split, Chorvatsko, 21000
-
Zagreb, Chorvatsko, 10000
-
-
-
-
-
Tampere, Finsko, 36280
-
Turku, Finsko, 20520
-
-
-
-
-
Avignon, Francie, 84082
-
Bordeaux, Francie, 33076
-
Bordeaux, Francie, 33075
-
Chambray-lès-tours, Francie, 37044
-
Limoges, Francie, 87042
-
Nimes, Francie, 30029
-
Pessac, Francie, 33604
-
Rouen, Francie, 76031
-
-
-
-
-
Bergamo, Itálie, 24128
-
Cattolica, Itálie, 47841
-
Rimini, Itálie, 47900
-
Udine, Itálie, 33100
-
-
-
-
-
Beer Sheva, Izrael, 8410101
-
Jerusalem, Izrael, 91031
-
Kfar Saba, Izrael, 44281
-
Petach Tikva, Izrael, 49100
-
Ramat-gan, Izrael, 52621
-
Rehovot, Izrael, 76100
-
Tel Aviv, Izrael, 6423906
-
-
-
-
-
Cape Town, Jižní Afrika, 7500
-
Durban, Jižní Afrika, 4001
-
Pietermaritzburg, Jižní Afrika, 3201
-
Port Elizabeth, Jižní Afrika, 6001
-
Pretoria, Jižní Afrika, 0001
-
-
-
-
Alberta
-
Edmonton, Alberta, Kanada, T6G 1Z2
-
-
Newfoundland and Labrador
-
St. John's, Newfoundland and Labrador, Kanada, A1B 3V6
-
-
Nova Scotia
-
Halifax, Nova Scotia, Kanada, B3H 1V7
-
-
Ontario
-
London, Ontario, Kanada, N6A 4L6
-
Oshawa, Ontario, Kanada, L1G 2B9
-
Ottawa, Ontario, Kanada, K1H 1C4
-
Saint Catherines, Ontario, Kanada, L2R 2Z7
-
Thunder Bay, Ontario, Kanada, P7A 7T1
-
Toronto, Ontario, Kanada, M5G 2M9
-
Weston, Ontario, Kanada, M9N 1N8
-
-
Quebec
-
Laval, Quebec, Kanada, H7M 3L9
-
Levis, Quebec, Kanada, G6V 3Z1
-
Montreal, Quebec, Kanada, H1T 2M4
-
Montreal, Quebec, Kanada, H2W 1S6
-
Montreal, Quebec, Kanada, H4J 1C5
-
Quebec City, Quebec, Kanada, G1R 2J6
-
-
Saskatchewan
-
Regina, Saskatchewan, Kanada, S4T 7T1
-
-
-
-
-
Buchun, Korejská republika, 420-021
-
Seoul, Korejská republika, 138-736
-
Seoul, Korejská republika, 110-744
-
Seoul, Korejská republika, 120-752
-
Seoul, Korejská republika, 133-792
-
Seoul, Korejská republika, 137-040
-
-
-
-
-
Tübingen, Německo, 72076
-
-
-
-
-
Bialystok, Polsko, 15-073
-
Krakow, Polsko, 31-501
-
Warszawa, Polsko, 02-781
-
Warszawa, Polsko, 04-394
-
-
-
-
-
San Juan, Portoriko, 00921-3201
-
-
-
-
-
Bratislava, Slovensko, 831 01
-
-
-
-
-
Ljubljana, Slovinsko, 1000
-
-
-
-
-
Denbigh, Spojené království, LL18 5UJ
-
Manchester, Spojené království, M20 4BX
-
Merseyside, Spojené království, CH63 45Y
-
Preston, Spojené království, PR2 9HT
-
-
-
-
California
-
Bakersfield, California, Spojené státy, 93309
-
-
Colorado
-
Colorado Springs, Colorado, Spojené státy, 80903
-
-
District of Columbia
-
Washington, District of Columbia, Spojené státy, 20007-2197
-
-
Indiana
-
Terre Haute, Indiana, Spojené státy, 47802
-
-
Missouri
-
St Louis, Missouri, Spojené státy, 63136
-
-
Montana
-
Billings, Montana, Spojené státy, 59101
-
-
New York
-
Nyack, New York, Spojené státy, 10960
-
-
Texas
-
Dallas, Texas, Spojené státy, 75204
-
-
-
-
-
Belgrade, Srbsko, 11000
-
-
-
-
-
Kueishan, Tchaj-wan
-
Tainan, Tchaj-wan, 704
-
Taipei, Tchaj-wan, 104
-
-
-
-
-
Heraklion, Řecko, 71110
-
Thessaloniki, Řecko, 56439
-
-
-
-
-
Barcelona, Španělsko, 08907
-
Leganes, Španělsko, 28911
-
Madrid, Španělsko, 28041
-
Madrid, Španělsko, 28035
-
Palma de Mallorca, Španělsko, 07014
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: 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).
|
1000 mg/m2 po nabídce ve dnech 1-15 každého 3týdenního cyklu
As prescribed, in 3 week cycles
As prescribed, in 2 week cycles
|
Aktivní komparátor: 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).
|
As prescribed, in 3 week cycles
As prescribed, in 2 week cycles
As prescribed, in 2 week cycles
As prescribed, in 2 week cycles
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Progression Free Survival
Časové okno: 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
|
Up to 3 years
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Progression Free Survival Based on Independent Review Committee Assessment
Časové okno: 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 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.
|
Up to 3 years
|
Progression Free Survival Based on Treatment Analysis- Intent To Treat Population
Časové okno: Up to 3 years
|
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.
|
Up to 3 years
|
Progression Free Survival Based on Treatment Analysis- Per Population
Časové okno: 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 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
|
Up to 3 years
|
Best Overall Response, Investigators' Assessments
Časové okno: Up to 3 years
|
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.
|
Up to 3 years
|
Best Overall Response, Independent Review Committee Assessment
Časové okno: Up to 3 years
|
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.
|
Up to 3 years
|
Overall Survival
Časové okno: Up to 3 years
|
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.
|
Up to 3 years
|
Time To Response
Časové okno: Up to 3 years
|
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.
|
Up to 3 years
|
Duration Of Response
Časové okno: Up to 3 years
|
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.
|
Up to 3 years
|
Time To Treatment Failure
Časové okno: Up to 3 years
|
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.
|
Up to 3 years
|
Number of Participants With Marked Post-baseline Laboratory Abnormalities by Trial Treatment
Časové okno: 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.
|
Up to 3 years
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. července 2003
Primární dokončení (Aktuální)
1. srpna 2006
Dokončení studie (Aktuální)
1. srpna 2006
Termíny zápisu do studia
První předloženo
15. září 2003
První předloženo, které splnilo kritéria kontroly kvality
17. září 2003
První zveřejněno (Odhad)
18. září 2003
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
1. dubna 2016
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
3. března 2016
Naposledy ověřeno
1. března 2016
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Nemoci trávicího systému
- Novotvary
- Novotvary podle místa
- Gastrointestinální novotvary
- Novotvary trávicího systému
- Gastrointestinální onemocnění
- Onemocnění tlustého střeva
- Střevní nemoci
- Střevní novotvary
- Rektální onemocnění
- Kolorektální novotvary
- Fyziologické účinky léků
- Molekulární mechanismy farmakologického působení
- Antimetabolity, Antineoplastika
- Antimetabolity
- Antineoplastická činidla
- Ochranné prostředky
- Mikroživiny
- Vitamíny
- Protijedy
- Vitamín B komplex
- Kapecitabin
- Oxaliplatina
- Leukovorin
Další identifikační čísla studie
- NO16967
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na kapecitabin [Xeloda]
-
RenJi HospitalAktivní, ne náborRakovina konečníku stadium IIIČína