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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XELOX | Experimental | 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). |
|
| FOLFOX-4 | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5 FU | Drug | As prescribed, in 2 week cycles |
| |
| Leucovorin |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival Based on Independent Review Committee Assessment | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bakersfield | California | 93309 | United States | |||
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The study was conducted from 09 Jul 2003 to 31 Aug 2006 at 87 centers in 19 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
As prescribed, in 2 week cycles |
|
| Oxaliplatin | Drug | As prescribed, in 3 week cycles |
|
| Oxaliplatin | Drug | As prescribed, in 2 week cycles |
|
| capecitabine [Xeloda] | Drug | 1000mg/m2 po bid on days 1-15 of each 3 week cycle |
|
| Up to 3 years |
| Progression Free Survival Based on Treatment Analysis- Intent To Treat Population | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Colorado Springs |
| Colorado |
| 80903 |
| United States |
| Washington D.C. | District of Columbia | 20007-2197 | United States |
| Terre Haute | Indiana | 47802 | United States |
| St Louis | Missouri | 63136 | United States |
| Billings | Montana | 59101 | United States |
| Nyack | New York | 10960 | United States |
| Dallas | Texas | 75204 | United States |
| Brussels | 1000 | Belgium |
| Brussels | 1070 | Belgium |
| Ghent | 9000 | Belgium |
| Kortrijk | 8500 | Belgium |
| Mont-godinne | 5530 | Belgium |
| Edmonton | Alberta | T6G 1Z2 | Canada |
| St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| Halifax | Nova Scotia | B3H 1V7 | Canada |
| London | Ontario | N6A 4L6 | Canada |
| Oshawa | Ontario | L1G 2B9 | Canada |
| Ottawa | Ontario | K1H 1C4 | Canada |
| Saint Catherines | Ontario | L2R 2Z7 | Canada |
| Thunder Bay | Ontario | P7A 7T1 | Canada |
| Toronto | Ontario | M5G 2M9 | Canada |
| Weston | Ontario | M9N 1N8 | Canada |
| Laval | Quebec | H7M 3L9 | Canada |
| Lévis | Quebec | G6V 3Z1 | Canada |
| Montreal | Quebec | H1T 2M4 | Canada |
| Montreal | Quebec | H2W 1S6 | Canada |
| Montreal | Quebec | H4J 1C5 | Canada |
| Québec | Quebec | G1R 2J6 | Canada |
| Regina | Saskatchewan | S4T 7T1 | Canada |
| Split | 21000 | Croatia |
| Zagreb | 10000 | Croatia |
| Tampere | 36280 | Finland |
| Turku | 20520 | Finland |
| Avignon | 84082 | France |
| Bordeaux | 33075 | France |
| Bordeaux | 33076 | France |
| Chambray-lès-Tours | 37044 | France |
| Limoges | 87042 | France |
| Nîmes | 30029 | France |
| Pessac | 33604 | France |
| Rouen | 76031 | France |
| Tübingen | 72076 | Germany |
| Heraklion | 71110 | Greece |
| Thessaloniki | 56439 | Greece |
| Beersheba | 8410101 | Israel |
| Jerusalem | 91031 | Israel |
| Kfar Saba | 44281 | Israel |
| Petah Tikva | 49100 | Israel |
| Ramat Gan | 52621 | Israel |
| Rehovot | 76100 | Israel |
| Tel Aviv | 6423906 | Israel |
| Bergamo | 24128 | Italy |
| Cattolica | 47841 | Italy |
| Rimini | 47900 | Italy |
| Udine | 33100 | Italy |
| Bialystok | 15-073 | Poland |
| Krakow | 31-501 | Poland |
| Warsaw | 02-781 | Poland |
| Warsaw | 04-394 | Poland |
| San Juan | 00921-3201 | Puerto Rico |
| Belgrade | 11000 | Serbia |
| Bratislava | 831 01 | Slovakia |
| Ljubljana | 1000 | Slovenia |
| Cape Town | 7500 | South Africa |
| Durban | 4001 | South Africa |
| Pietermaritzburg | 3201 | South Africa |
| Port Elizabeth | 6001 | South Africa |
| Pretoria | 0001 | South Africa |
| Buchun | 420-021 | South Korea |
| Seoul | 110-744 | South Korea |
| Seoul | 120-752 | South Korea |
| Seoul | 133-792 | South Korea |
| Seoul | 137-040 | South Korea |
| Seoul | 138-736 | South Korea |
| Barcelona | 08907 | Spain |
| Leganés | 28911 | Spain |
| Madrid | 28035 | Spain |
| Madrid | 28041 | Spain |
| Palma de Mallorca | 07014 | Spain |
| Kueishan | Taiwan |
| Tainan | 704 | Taiwan |
| Taipei | 104 | Taiwan |
| Denbigh | LL18 5UJ | United Kingdom |
| Manchester | M20 4BX | United Kingdom |
| Merseyside | CH63 45Y | United Kingdom |
| Preston | PR2 9HT | United Kingdom |
| FG001 | 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/m2 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). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants with written informed consent who were randomized to one of the two study arms were included in the Intent-to-treat (ITT) population. Participants in this population were analyzed according to the arm to which they were randomized
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | XELOX | Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 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). |
| BG001 | 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/m2 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival | 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 | The per protocol (PP) population included randomized participants who received at least one dose of capecitabine, 5-FU, or oxaliplatin, or who did not had a major violation of protocol inclusion or exclusion criteria assessments. | Posted | Median | 95% Confidence Interval | days | Up to 3 years |
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|
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| Secondary | Progression Free Survival Based on Independent Review Committee Assessment | 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. | PP population excluded randomized participants who did not receive at least one dose of Capecitabine, 5-FU, or Oxaliplatin, or who had a major violation of protocol inclusion or exclusion criteria. | Posted | Median | 95% Confidence Interval | days | Up to 3 years |
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| Secondary | Progression Free Survival Based on Treatment Analysis- Intent To Treat Population | 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. | All participants who were randomized to one of the two study arms were included in the Intent To Treat (ITT) population. Participants were analyzed according to the arm to which they were randomized. | Posted | Median | 95% Confidence Interval | days | Up to 3 years |
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| Secondary | Progression Free Survival Based on Treatment Analysis- Per Population | 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 | The PP population included randomized participants who received at least one dose of Capecitabine, 5-FU, or Oxaliplatin, or who did not had a major violation of protocol inclusion or exclusion criteria assessments. | Posted | Median | 95% Confidence Interval | days | Up to 3 years |
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| Secondary | Best Overall Response, Investigators' Assessments | 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. | All participants who were randomized to one of the two study arms were included in the ITT population. Participants in this population were analyzed according to the arm to which they were randomized. | Posted | Number | participants | Up to 3 years |
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| Secondary | Best Overall Response, Independent Review Committee Assessment | 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. | All participants who were randomized to one of the two study arms were included in the ITT population. Participants in this population were analyzed according to the arm to which they were randomized. | Posted | Number | participants | Up to 3 years |
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| Secondary | Overall Survival | 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. | All participants who were randomized to one of the two study arms were included in the ITT population. Participants in this population were analyzed according to the arm to which they were randomized. | Posted | Median | 95% Confidence Interval | days | Up to 3 years |
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| Secondary | Time To Response | 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. | All participants who were randomized to one of the two study arms were included in the ITT population. Participants in this population were analyzed according to the arm to which they were randomized. | Posted | Number | participants | Up to 3 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration Of Response | 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. | All participants who were randomized to one of the two study arms were included in the Intent-to-treat (ITT) population. Participants in this population were analyzed according to the arm to which they were randomized. | Posted | Median | 95% Confidence Interval | days | Up to 3 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time To Treatment Failure | 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. | All participants who were randomized and received at least one dose of capecitabine, 5-FU, or oxaliplatin were included in the safety population. The safety population was used for the analyses of all safety parameters. | Posted | Median | 95% Confidence Interval | days | Up to 3 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Marked Post-baseline Laboratory Abnormalities by Trial Treatment | 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. | All participants who were randomized and received at least one dose of capecitabine, 5-FU, or oxaliplatin were included in the safety population. The safety population was used for the analyses of all safety parameters | Posted | Number | participants | Up to 3 years |
|
Up to 3 years
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who were randomized and received at least one dose of capecitabine, 5-FU, or oxaliplatin and had a safety assessment performed post baseline.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). | 94 | 311 | 302 | 311 | ||
| EG001 | 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). | 97 | 308 | 298 | 308 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| *Stomatitis all | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Colonic pseudo-obstruction | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Colonic stenosis | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Central line infection | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Gastroenteritis salmonella | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Pelvic inflammatory disease | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Postoperative abscess | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Warm type haemolytic anaemia | Blood and lymphatic system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Catheter related complication | General disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (8.0) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Hyperglycaemic hyperosmolar nonketotic syndrome | Metabolism and nutrition disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Dysaesthesia pharynx | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Superior vena caval occlusionq | Vascular disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Osteoporotic fracture | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Spinal disorder | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Hepatic pain | Hepatobiliary disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA (8.0) | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (8.0) | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (8.0) | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (8.0) | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA (8.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Abdominal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | Systematic Assessment |
| |
| Rectal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Analgesic therapy | Surgical and medical procedures | MedDRA (8.0) | Systematic Assessment |
| |
| Urinary tract operation | Surgical and medical procedures | MedDRA (8.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (8.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Stomatitis all | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Neuropathy | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Temperature intolerance | General disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Dysaesthesia pharynx | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (8.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roche Trial Information Hotline | F. Hoffmann-La Roche AG | +41 61 6878333 | global.trial_information@roche.com |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002955 | Leucovorin |
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Male |
|
| OG001 | 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/m2 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). |
|
|
|
| OG001 | 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/m2 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). |
|
|
|
| OG001 | 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/m2 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). |
|
|
|
| OG001 | 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/m2 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). |
|
|
|
| OG001 | 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/m2 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). |
|
|
|
|
|
|
|
|
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/m2 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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|
|
|
|
|
|