A Phase 2 interventional study of 5-FU and 5-FU in Colorectal Cancer, sponsored by Hoffmann-La Roche. Completed at 19 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
This 2 arm study will compare the resection rate of liver metastases and safety of surgery in patients with metastatic colorectal cancer and primarily unresectable liver metastases receiving treatment with Avastin in combination with 5-FU, leucovorin and oxaliplatin with irinotecan (FOLFOXIRI) or without irinotecan (mFOLFOX-6) as first line treatment. Patients will be randomized to receive Avastin (5mg/kg iv every 2 weeks) in combination with each of these two standard neoadjuvant chemotherapy regimens. The anticipated time on study treatment is until surgery, disease progression, unacceptable toxicity or patient refusal, and the target sample size is \<100 individuals.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 80 is close to the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: 5-FU · Drug: Leucovorin · Drug: Oxaliplatin · Drug: bevacizumab [Avastin]
Drug: 5-FU · Drug: Irinotecan · Drug: Leucovorin · Drug: Oxaliplatin · Drug: bevacizumab [Avastin]
Bolus 400mg/m2, day 1 every 2 weeks
3200mg/m2 46-hour continuous iv infusion, day 1 every 2 weeks
2400mg/m2 46-hour continuous iv infusion, day 1 every 2 weeks
165mg/m2 1-hour iv infusion, day 1 every 2 weeks
400mg/m2 2-hour iv infusion, day 1 every 2 weeks
200mg/m2 2-hour iv infusion, day 1 every 2 weeks
85mg/m2 2-hour iv infusion, day 1 every 2 weeks
5mg/kg iv day 1 every 2 weeks
Percentage of Participants With Complete Resection or Residual (Microscopic or Macroscopic) Tumor
Following resective surgery, participants were evaluated for complete resection (R0) or the presence of microscopic (R1) or macroscopic (R2) residual tumor. The percentage of participants within each residual tumor classification was calculated as \[number of participants with R0, R1, and/or R2 divided by the total number of participants\] multiplied by 100. Associated 95% confidence intervals were calculated for one-sample binomial using the Clopper-Pearson method.
Time frame: Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; and at time of/after surgery)
Time to Resection
Time to resection was defined as the time from randomization to the date of first resective surgery. For participants who did not undergo resective surgery, time to resection was censored at Day 1. Time to resection was estimated by Kaplan-Meier analysis.
Time frame: Up to 5 years (at Screening; prior to each cycle, and within 7 days prior to surgery; and at time of surgery)
Percentage of Participants With Histopathological Response
At the time of resective surgery, participants were evaluated for histopathological response as defined through pathologist review of the resected metastatic lesions, including assessment of margin status and tumor cell viability. Histopathological response classification was based upon the percentage of viable tumor cells, where 'Complete response' was considered for those with 0 percent (%) viable tumor cells, 'Major response' for those with 1% to 49% viable tumor cells, 'Minor response' for 50% to 99% viable tumor cells, and 'No response' for 100% viable tumor cells. The response could not be determined in some cases and was documented as 'Unknown.' The percentage of participants within each response category was calculated as \[number of participants with a given response divided by the number of participants who completed the assessment\] multiplied by 100.
Time frame: Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; and at time of/after surgery)
Percentage of Participants With Complete or Major Histopathological Response
At the time of resective surgery, participants were evaluated for histopathological response as defined through pathologist review of the resected metastatic lesions, including assessment of margin status and tumor cell viability. Histopathological response classification was based upon the percentage of viable tumor cells, as described previously. The collective percentage of participants assessed as having a complete or major response was calculated as \[number of participants with complete or major response divided by the number of participants who completed the assessment\] multiplied by 100. Associated 95% confidence intervals were calculated for one-sample binomial using the Clopper-Pearson method.
Time frame: Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; and at time of/after surgery)
Percentage of Participants Experiencing Relapse Following Curative Resection
Among participants with curative resection (complete resection \[R0\] or microscopic residual tumor \[R1\]), relapse was defined as the first new occurrence of cancer or death. The percentage of participants who experienced relapse was calculated as \[number of participants with a relapse event divided by the number of participants initially classified as R0 or R1 following resective surgery\] multiplied by 100.
Time frame: Up to 5 years (at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)
Relapse-Free Survival (RFS)
RFS was defined as the time from curative resection (complete resection \[R0\] or microscopic residual tumor \[R1\]) to the date of first diagnosis of relapse. For participants with curative resection and without relapse, RFS was censored at the last known relapse-free assessment. RFS was estimated by Kaplan-Meier analysis.
Time frame: Up to 5 years (at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)
Percentage of Participants Experiencing Death or Disease Progression
PD was defined, using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, as at least a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions. The percentage of participants experiencing PD or death was calculated as \[number of participants with event divided by the number of participants analyzed\] multiplied by 100.
Time frame: Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; 4 and 12 weeks after surgery; and at the end of Cycles 4 and 8 if assessed as R0 or R1, or every 6 weeks until progression or resectability if assessed as R2)
Progression-Free Survival (PFS)
PFS was defined, using RECIST version 1.0, as the time from randomization to the date of first documented PD or death from any cause. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions. For participants without documented PD or death, PFS was censored at the time of last tumor assessment. PFS was estimated by Kaplan-Meier analysis.
Time frame: Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; 4 and 12 weeks after surgery; and at the end of Cycles 4 and 8 if assessed as R0 or R1, or every 6 weeks until progression or resectability if assessed as R2)
Percentage of Participants Who Died
Time frame: Up to 5 years (prior to each cycle, and within 7 days prior to surgery; at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)
Overall Survival (OS)
OS was defined as the time from randomization to death from any cause. For participants without an event of death, OS was censored at the last-known alive date. OS was estimated by Kaplan-Meier analysis.
Time frame: Up to 5 years (prior to each cycle, and within 7 days prior to surgery; at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)
Percentage of Participants With a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.0
Using RECIST version 1.0, participants were considered to have achieved CR upon the disappearance of all target and non-target lesions. Participants who achieved PR demonstrated at least a 30% decrease in the sum of the largest diameter of target lesions, taking as reference the Screening sum largest diameter. Responses were confirmed by repeat assessments no less than 4 weeks after criteria for response were first met. The collective percentage of participants with confirmed best overall response of CR or PR was calculated as \[number of participants meeting RECIST criteria for CR or PR divided by the number of participants analyzed\] multiplied by 100. Associated 95% confidence intervals were calculated for one-sample binomial using the Clopper-Pearson method.
Time frame: Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; 4 and 12 weeks after surgery; and at the end of Cycles 4 and 8 if assessed as R0 or R1, or every 6 weeks until progression or resectability if assessed as R2)
Time to Response
Time to response according to RECIST version 1.0 was defined as the time from randomization to the date of first documented CR or PR. Participants were considered to have achieved CR upon the disappearance of all target and non-target lesions. Participants who achieved PR demonstrated at least a 30% decrease in the sum of the largest diameter of target lesions, taking as reference the Screening sum largest diameter. Responses were confirmed by repeat assessments no less than 4 weeks after criteria for response were first met. For participants who did not complete a confirmatory tumor assessment, time to response was censored at the date of last tumor assessment, or if unavailable, at the date of first dose. Time to response was estimated by Kaplan-Meier analysis.
Time frame: Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; 4 and 12 weeks after surgery; and at the end of Cycles 4 and 8 if assessed as R0 or R1, or every 6 weeks until progression or resectability if assessed as R2)
Percentage of Participants With Complications Related to First Resective Surgery
Complications related to the first resective surgery were evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0, and classified according to severity. The NCI-CTCAE severity classification criteria are as follows: Grade 5 equals (=) resulting in death; Grade 4 = life-threatening; Grade 3 = severe; Grade 2 = moderate; and Grade 1 = mild. The percentage of participants experiencing a given adverse event (AE) by severity grade was calculated as \[number of participants with an AE divided by the number of participants who underwent first resective surgery\] multiplied by 100.
Time frame: Up to 5 years (at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)
Percentage of Participants With Complications Related to Second Resective Surgery
Complications related to the second resective surgery were evaluated using the NCI-CTCAE version 3.0, and classified according to severity. The NCI-CTCAE severity classification criteria are as follows: Grade 5 = resulting in death; Grade 4 = life-threatening; Grade 3 = severe; Grade 2 = moderate; and Grade 1 = mild. The percentage of participants experiencing a given AE by severity grade was calculated as \[number of participants with an AE divided by the number of participants who underwent second resective surgery\] multiplied by 100.
Time frame: Up to 5 years (at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)
| Milestone | Bevacizumab + mFOLFOX-6 | Bevacizumab + FOLFOXIRI |
|---|---|---|
| Started | 39 | 41 |
| Completed | 18 | 19 |
| Not completed | 21 | 22 |
| Withdrew: Adverse event | 8 | 5 |
| Withdrew: Death | 1 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Violation of selection criteria | 1 | 1 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Refused treatment | 2 | 3 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Administrative reason | 7 | 10 |
Following resective surgery, participants were evaluated for complete resection (R0) or the presence of microscopic (R1) or macroscopic (R2) residual tumor. The percentage of participants within each residual tumor classification was calculated as \[number of participants with R0, R1, and/or R2 divided by the total number of participants\] multiplied by 100. Associated 95% confidence intervals were calculated for one-sample binomial using the Clopper-Pearson method.
| percentage of participants | Bevacizumab + mFOLFOX-6 | Bevacizumab + FOLFOXIRI |
|---|---|---|
| R0, R1, or R2 | 48.7 (32.4 to 65.2) | 61.0 (44.5 to 75.8) |
| R0 or R1 | 33.3 (19.1 to 50.2) | 51.2 (35.1 to 67.1) |
| R0 | 23.1 (11.1 to 39.3) | 48.8 (32.9 to 64.9) |
Time to resection was defined as the time from randomization to the date of first resective surgery. For participants who did not undergo resective surgery, time to resection was censored at Day 1. Time to resection was estimated by Kaplan-Meier analysis.
| months | Bevacizumab + mFOLFOX-6 | Bevacizumab + FOLFOXIRI |
|---|---|---|
| Time to Resection | 4.4 (4.1 to 5.8) | 4.3 (3.9 to 5.5) |
At the time of resective surgery, participants were evaluated for histopathological response as defined through pathologist review of the resected metastatic lesions, including assessment of margin status and tumor cell viability. Histopathological response classification was based upon the percentage of viable tumor cells, where 'Complete response' was considered for those with 0 percent (%) viable tumor cells, 'Major response' for those with 1% to 49% viable tumor cells, 'Minor response' for 50% to 99% viable tumor cells, and 'No response' for 100% viable tumor cells. The response could not be determined in some cases and was documented as 'Unknown.' The percentage of participants within each response category was calculated as \[number of participants with a given response divided by the number of participants who completed the assessment\] multiplied by 100.
| percentage of participants | Bevacizumab + mFOLFOX-6 | Bevacizumab + FOLFOXIRI |
|---|---|---|
| Complete response | 0 | 4.8 |
| Major response | 57.1 | 47.6 |
| Minor response | 28.6 | 33.3 |
| No response | 0 | 0 |
| Unknown | 14.3 | 14.3 |
At the time of resective surgery, participants were evaluated for histopathological response as defined through pathologist review of the resected metastatic lesions, including assessment of margin status and tumor cell viability. Histopathological response classification was based upon the percentage of viable tumor cells, as described previously. The collective percentage of participants assessed as having a complete or major response was calculated as \[number of participants with complete or major response divided by the number of participants who completed the assessment\] multiplied by 100. Associated 95% confidence intervals were calculated for one-sample binomial using the Clopper-Pearson method.
| percentage of participants | Bevacizumab + mFOLFOX-6 | Bevacizumab + FOLFOXIRI |
|---|---|---|
| Percentage of Participants With Complete or Major Histopathological Response | 57.1 (28.9 to 82.3) | 52.4 (29.8 to 74.3) |
Among participants with curative resection (complete resection \[R0\] or microscopic residual tumor \[R1\]), relapse was defined as the first new occurrence of cancer or death. The percentage of participants who experienced relapse was calculated as \[number of participants with a relapse event divided by the number of participants initially classified as R0 or R1 following resective surgery\] multiplied by 100.
| percentage of participants | Bevacizumab + mFOLFOX-6 | Bevacizumab + FOLFOXIRI |
|---|---|---|
| Percentage of Participants Experiencing Relapse Following Curative Resection | 76.9 | 57.1 |
RFS was defined as the time from curative resection (complete resection \[R0\] or microscopic residual tumor \[R1\]) to the date of first diagnosis of relapse. For participants with curative resection and without relapse, RFS was censored at the last known relapse-free assessment. RFS was estimated by Kaplan-Meier analysis.
| months | Bevacizumab + mFOLFOX-6 | Bevacizumab + FOLFOXIRI |
|---|---|---|
| Relapse-Free Survival (RFS) | 8.1 (3.8 to 11.7) | 17.1 (12.3 to NA) |
PD was defined, using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, as at least a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions. The percentage of participants experiencing PD or death was calculated as \[number of participants with event divided by the number of participants analyzed\] multiplied by 100.
| percentage of participants | Bevacizumab + mFOLFOX-6 | Bevacizumab + FOLFOXIRI |
|---|---|---|
| Percentage of Participants Experiencing Death or Disease Progression | 89.7 | 68.3 |
PFS was defined, using RECIST version 1.0, as the time from randomization to the date of first documented PD or death from any cause. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions. For participants without documented PD or death, PFS was censored at the time of last tumor assessment. PFS was estimated by Kaplan-Meier analysis.
| months | Bevacizumab + mFOLFOX-6 | Bevacizumab + FOLFOXIRI |
|---|---|---|
| Progression-Free Survival (PFS) | 11.5 (9.6 to 13.6) | 18.6 (12.9 to 22.3) |
| percentage of participants | Bevacizumab + mFOLFOX-6 | Bevacizumab + FOLFOXIRI |
|---|---|---|
| Percentage of Participants Who Died | 48.7 | 19.5 |
OS was defined as the time from randomization to death from any cause. For participants without an event of death, OS was censored at the last-known alive date. OS was estimated by Kaplan-Meier analysis.
| months | Bevacizumab + mFOLFOX-6 | Bevacizumab + FOLFOXIRI |
|---|---|---|
| Overall Survival (OS) | 32.2 (21.5 to NA) | NA (NA to NA) |
Using RECIST version 1.0, participants were considered to have achieved CR upon the disappearance of all target and non-target lesions. Participants who achieved PR demonstrated at least a 30% decrease in the sum of the largest diameter of target lesions, taking as reference the Screening sum largest diameter. Responses were confirmed by repeat assessments no less than 4 weeks after criteria for response were first met. The collective percentage of participants with confirmed best overall response of CR or PR was calculated as \[number of participants meeting RECIST criteria for CR or PR divided by the number of participants analyzed\] multiplied by 100. Associated 95% confidence intervals were calculated for one-sample binomial using the Clopper-Pearson method.
| percentage of participants | Bevacizumab + mFOLFOX-6 | Bevacizumab + FOLFOXIRI |
|---|---|---|
| Percentage of Participants With a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.0 | 61.5 (44.6 to 76.6) | 80.5 (65.1 to 91.2) |
Time to response according to RECIST version 1.0 was defined as the time from randomization to the date of first documented CR or PR. Participants were considered to have achieved CR upon the disappearance of all target and non-target lesions. Participants who achieved PR demonstrated at least a 30% decrease in the sum of the largest diameter of target lesions, taking as reference the Screening sum largest diameter. Responses were confirmed by repeat assessments no less than 4 weeks after criteria for response were first met. For participants who did not complete a confirmatory tumor assessment, time to response was censored at the date of last tumor assessment, or if unavailable, at the date of first dose. Time to response was estimated by Kaplan-Meier analysis.
| months | Bevacizumab + mFOLFOX-6 | Bevacizumab + FOLFOXIRI |
|---|---|---|
| Time to Response | 3.1 (2.7 to 8.6) | 3.1 (1.9 to 3.9) |
Complications related to the first resective surgery were evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0, and classified according to severity. The NCI-CTCAE severity classification criteria are as follows: Grade 5 equals (=) resulting in death; Grade 4 = life-threatening; Grade 3 = severe; Grade 2 = moderate; and Grade 1 = mild. The percentage of participants experiencing a given adverse event (AE) by severity grade was calculated as \[number of participants with an AE divided by the number of participants who underwent first resective surgery\] multiplied by 100.
| percentage of participants | Bevacizumab + mFOLFOX-6 | Bevacizumab + FOLFOXIRI |
|---|---|---|
| Any complication, Total | 73.7 | 52.0 |
| Any complication, Grade 1 | 15.8 | 4.0 |
| Any complication, Grade 2 | 36.8 | 12.0 |
| Any complication, Grade 3 | 10.5 | 24.0 |
| Any complication, Grade 4 | 0 | 12.0 |
| Any complication, Grade 5 | 10.5 | 0 |
| Bleeding, Total | 15.8 | 8.0 |
| Bleeding, Grade 1 | 5.3 | 0 |
| Bleeding, Grade 2 | 5.3 | 4.0 |
| Bleeding, Grade 3 | 5.3 | 4.0 |
| Cardiovascular, Total | 10.5 | 4.0 |
| Cardiovascular, Grade 2 | 0 | 4.0 |
| Cardiovascular, Grade 3 | 5.3 | 0 |
| Cardiovascular, Grade 4 | 5.3 | 0 |
| Infections, Total | 26.3 | 32.0 |
| Infections, Grade 1 | 10.5 | 12.0 |
| Infections, Grade 2 | 5.3 | 0 |
| Infections, Grade 3 | 5.3 | 16.0 |
| Infections, Grade 4 | 5.3 | 4.0 |
| Liver insufficiency, Total | 10.5 | 0 |
| Liver insufficiency, Grade 5 | 10.5 | 0 |
| Neural disorder, Total | 5.3 | 0 |
| Neural disorder, Grade 2 | 5.3 | 0 |
| Noninfected perihepatic fluid collections, Total | 0 | 4.0 |
| Noninfected perihepatic fluid collections, Grade 2 | 0 | 4.0 |
| Other complication, Total | 52.6 | 28.0 |
| Other complication, Grade 1 | 26.3 | 8.0 |
| Other complication, Grade 2 | 21.1 | 8.0 |
| Other complication, Grade 3 | 0 | 12.0 |
| Other complication, Grade 4 | 5.3 | 0 |
| Pulmonary, Total | 5.3 | 4.0 |
| Pulmonary, Grade 3 | 5.3 | 4.0 |
| Renal impairment, Total | 10.5 | 4.0 |
| Renal impairment, Grade 2 | 5.3 | 4.0 |
| Renal impairment, Grade 4 | 5.3 | 0 |
| Wound healing, Total | 5.3 | 12.0 |
| Wound healing, Grade 1 | 5.3 | 0 |
| Wound healing, Grade 3 | 0 | 4.0 |
| Wound healing, Grade 4 | 0 | 8.0 |
Complications related to the second resective surgery were evaluated using the NCI-CTCAE version 3.0, and classified according to severity. The NCI-CTCAE severity classification criteria are as follows: Grade 5 = resulting in death; Grade 4 = life-threatening; Grade 3 = severe; Grade 2 = moderate; and Grade 1 = mild. The percentage of participants experiencing a given AE by severity grade was calculated as \[number of participants with an AE divided by the number of participants who underwent second resective surgery\] multiplied by 100.
| percentage of participants | Bevacizumab + mFOLFOX-6 | Bevacizumab + FOLFOXIRI |
|---|---|---|
| Any complication, Total | 100.0 | 66.7 |
| Any complication, Grade 1 | 0 | 33.3 |
| Any complication, Grade 2 | 66.7 | 0 |
| Any complication, Grade 3 | 0 | 33.3 |
| Any complication, Grade 3a | 33.3 | 0 |
| Bleeding, Total | 33.3 | 33.3 |
| Bleeding, Grade 1 | 0 | 33.3 |
| Bleeding, Grade 2 | 33.3 | 0 |
Collected over Up to 5 years (at Screening; prior to each cycle, and within 7 days prior to surgery; at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bevacizumab + mFOLFOX-6 | — | 24/37 (64.9%) | 36/37 (97.3%) |
| Bevacizumab + FOLFOXIRI | — | 24/40 (60%) | 40/40 (100%) |
| Event | Bevacizumab + mFOLFOX-6 | Bevacizumab + FOLFOXIRI |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 1/37 | 6/40 |
| Febrile neutropeniaBlood and lymphatic system disorders | 3/37 | 6/40 |
| NeutropeniaBlood and lymphatic system disorders | 3/37 | 4/40 |
| Wound dehiscenceInjury, poisoning and procedural complications | 0/37 | 3/40 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 2/37 | 1/40 |
| Deep vein thrombosisVascular disorders | 2/37 | 2/40 |
| Hepatic failureHepatobiliary disorders | 2/37 | 0/40 |
| PeritonitisInfections and infestations | 0/37 | 2/40 |
| PyrexiaGeneral disorders | 0/37 | 2/40 |
| Abdominal painGastrointestinal disorders | 1/37 | 1/40 |
| Event | Bevacizumab + mFOLFOX-6 | Bevacizumab + FOLFOXIRI |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 20/37 | 33/40 |
| NeutropeniaBlood and lymphatic system disorders | 20/37 | 26/40 |
| VomitingGastrointestinal disorders | 14/37 | 25/40 |
| NauseaGastrointestinal disorders | 23/37 | 21/40 |
| Neuropathy peripheralNervous system disorders | 22/37 | 19/40 |
| Mucosal inflammationGeneral disorders | 20/37 | 17/40 |
| ConstipationGastrointestinal disorders | 18/37 | 15/40 |
| Abdominal painGastrointestinal disorders | 15/37 | 15/40 |
| AstheniaGeneral disorders | 14/37 | 16/40 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 13/37 | 16/40 |
Intent-to-Treat (ITT) Population: All randomized participants. Participants were analyzed according to which treatment group they were randomized, regardless of the treatment actually received.
| Age, Continuous(years) | Bevacizumab + mFOLFOX-6 | Bevacizumab + FOLFOXIRI | Total |
|---|---|---|---|
| Mean | 57.1 ± 10.32 | 61.8 ± 11.02 | 59.5 ± 10.87 |
| Gender(Participants) | Bevacizumab + mFOLFOX-6 | Bevacizumab + FOLFOXIRI | Total |
|---|---|---|---|
| Female | 21 | 12 | 33 |
| Male | 18 | 29 | 47 |
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