- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT00069108
A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer
torstai 3. maaliskuuta 2016 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Valmis
Ehdot
Interventio / Hoito
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
627
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Bruxelles, Belgia, 1070
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Bruxelles, Belgia, 1000
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Gent, Belgia, 9000
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Kortrijk, Belgia, 8500
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Mont-godinne, Belgia, 5530
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Barcelona, Espanja, 08907
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Leganes, Espanja, 28911
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Madrid, Espanja, 28041
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Madrid, Espanja, 28035
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Palma de Mallorca, Espanja, 07014
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Cape Town, Etelä-Afrikka, 7500
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Durban, Etelä-Afrikka, 4001
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Pietermaritzburg, Etelä-Afrikka, 3201
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Port Elizabeth, Etelä-Afrikka, 6001
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Pretoria, Etelä-Afrikka, 0001
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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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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, Korean tasavalta, 420-021
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Seoul, Korean tasavalta, 138-736
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Seoul, Korean tasavalta, 110-744
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Seoul, Korean tasavalta, 120-752
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Seoul, Korean tasavalta, 133-792
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Seoul, Korean tasavalta, 137-040
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Heraklion, Kreikka, 71110
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Thessaloniki, Kreikka, 56439
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Split, Kroatia, 21000
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Zagreb, Kroatia, 10000
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San Juan, Puerto Rico, 00921-3201
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Bialystok, Puola, 15-073
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Krakow, Puola, 31-501
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Warszawa, Puola, 02-781
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Warszawa, Puola, 04-394
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Avignon, Ranska, 84082
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Bordeaux, Ranska, 33076
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Bordeaux, Ranska, 33075
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Chambray-lès-tours, Ranska, 37044
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Limoges, Ranska, 87042
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Nimes, Ranska, 30029
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Pessac, Ranska, 33604
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Rouen, Ranska, 76031
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Tübingen, Saksa, 72076
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Belgrade, Serbia, 11000
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Bratislava, Slovakia, 831 01
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Ljubljana, Slovenia, 1000
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Tampere, Suomi, 36280
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Turku, Suomi, 20520
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Kueishan, Taiwan
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Tainan, Taiwan, 704
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Taipei, Taiwan, 104
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Denbigh, Yhdistynyt kuningaskunta, LL18 5UJ
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Manchester, Yhdistynyt kuningaskunta, M20 4BX
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Merseyside, Yhdistynyt kuningaskunta, CH63 45Y
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Preston, Yhdistynyt kuningaskunta, PR2 9HT
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California
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Bakersfield, California, Yhdysvallat, 93309
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Colorado
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Colorado Springs, Colorado, Yhdysvallat, 80903
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District of Columbia
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Washington, District of Columbia, Yhdysvallat, 20007-2197
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Indiana
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Terre Haute, Indiana, Yhdysvallat, 47802
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Missouri
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St Louis, Missouri, Yhdysvallat, 63136
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Montana
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Billings, Montana, Yhdysvallat, 59101
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New York
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Nyack, New York, Yhdysvallat, 10960
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Texas
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Dallas, Texas, Yhdysvallat, 75204
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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 bid jokaisen 3 viikon syklin päivinä 1-15
As prescribed, in 3 week cycles
As prescribed, in 2 week cycles
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Active Comparator: 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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Progression Free Survival
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Progression Free Survival Based on Independent Review Committee Assessment
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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.
|
Up to 3 years
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Time To Treatment Failure
Aikaikkuna: 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.
|
Up to 3 years
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Number of Participants With Marked Post-baseline Laboratory Abnormalities by Trial Treatment
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Tiistai 1. heinäkuuta 2003
Ensisijainen valmistuminen (Todellinen)
Tiistai 1. elokuuta 2006
Opintojen valmistuminen (Todellinen)
Tiistai 1. elokuuta 2006
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Maanantai 15. syyskuuta 2003
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Keskiviikko 17. syyskuuta 2003
Ensimmäinen Lähetetty (Arvio)
Torstai 18. syyskuuta 2003
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Perjantai 1. huhtikuuta 2016
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Torstai 3. maaliskuuta 2016
Viimeksi vahvistettu
Tiistai 1. maaliskuuta 2016
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Ruoansulatuskanavan sairaudet
- Neoplasmat
- Neoplasmat sivustoittain
- Ruoansulatuskanavan kasvaimet
- Ruoansulatuskanavan kasvaimet
- Ruoansulatuskanavan sairaudet
- Paksusuolen sairaudet
- Suoliston sairaudet
- Suoliston kasvaimet
- Peräsuolen sairaudet
- Kolorektaaliset kasvaimet
- Huumeiden fysiologiset vaikutukset
- Farmakologisen vaikutuksen molekyylimekanismit
- Antimetaboliitit, antineoplastiset
- Antimetaboliitit
- Antineoplastiset aineet
- Suojaavat aineet
- Mikroravinteet
- Vitamiinit
- Vastalääkkeet
- B-vitamiinikompleksi
- Kapesitabiini
- Oksaliplatiini
- Leukovoriini
Muut tutkimustunnusnumerot
- NO16967
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
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Fore BiotherapeuticsRekrytointiCancer sisältää BRAF-muutoksiaYhdysvallat, Saksa, Espanja, Yhdistynyt kuningaskunta, Ranska, Korean tasavalta, Italia, Ruotsi, Kanada
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Samsung Medical CenterValmisHER2-positiivinen Refractory Advanced CancerKorean tasavalta
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Gynecologic Oncology GroupNational Cancer Institute (NCI)Aktiivinen, ei rekrytointiVaiheen III vulvar Cancer AJCC v7 | Vaihe IIIA Vulvar Cancer AJCC v7 | Vaihe IIIB Vulvar Cancer AJCC v7 | Vaihe IIIC Vulvar Cancer AJCC v7 | Epäsuoran levyepiteelisyöpä | Stage IVA Vulvar Cancer AJCC v7Yhdysvallat
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RekrytointiVaiheen II Vulvar Cancer AJCC v8 | Vaiheen IIIC vulvar Cancer AJCC v8 | Stage IVA Vulvar Cancer AJCC v8 | Kolmannen vaiheen ulkosynnyttäjäsyöpä AJCC v8 | Vaihe IIIA Vulvar Cancer AJCC v8 | Vaihe IIIB Vulvar Cancer AJCC v8Yhdysvallat
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University of UtahNational Cancer Institute (NCI)RekrytointiVäsymys | Istuva elämäntapa | Metastaattinen eturauhassyöpä | Stage IV Prostate Cancer AJCC (American Joint Committee on Cancer) v8 | Stage IVA Eturauhassyöpä AJCC (American Joint Committee on Cancer) v8 | Stage IVB Eturauhassyöpä AJCC (American Joint Committee on Cancer) v8Yhdysvallat
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Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...ValmisTutki kiinalaisia naisia, jotka eivät ole noudattaneet American Cancer Societyn mammografiaseulontaohjeitaYhdysvallat
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)ValmisOhutsuolen adenokarsinooma | Vaihe III ohutsuolen adenokarsinooma AJCC v8 | Vaihe IIIA ohutsuolen adenokarsinooma AJCC v8 | Vaihe IIIB ohutsuolen adenokarsinooma AJCC v8 | IV vaiheen ohutsuolen adenokarsinooma AJCC v8 | Vater-adenokarsinooman ampulla | Vaiheen III ampulla Vater Cancer AJCC v8 | Vaiheen... ja muut ehdotYhdysvallat
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Massachusetts General HospitalValmisColoRectal syövän seulonta
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Centre Francois BaclesseLigue contre le cancer, FranceRekrytointiPitkäaikaiset syövän sivuvaikutukset | Tukihoito syövän hoidossa | Cancer Survivorship Care Plan | Edistynyt sairaanhoitaja | Lantion gynekologinen syöpäRanska
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