A Phase 3 interventional study of FOLFOX6m and SIR-Spheres microspheres in Colorectal Cancer Metastatic, sponsored by Sirtex Medical. Completed at 83 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-05.
Sponsored by Sirtex Medical · Phase 3, Interventional, and Treatment
This study is a randomized, multi-center study that will compare the efficacy and safety of selective internal radiation therapy (SIRT) using SIR-Spheres microspheres plus a standard chemotherapy regimen of FOLFOX6m versus FOLFOX6m alone as first-line therapy in patients with non-resectable liver metastases from primary colorectal carcinoma.
Treatment with the biologic agent bevacizumab, if part of the standard of care at participating institutions, is allowed within this study at the discretion of the Investigator.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 209 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Sirtex Medical is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure.
Drug: FOLFOX6m
Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.
Drug: FOLFOX6m · Device: SIR-Spheres microspheres
Overall Survival (OS)
OS defined as the time interval between the date of randomization and the date of death from any cause.
Time frame: From date of randomization until the date of death from any cause assessed up 3 yrs 8 months
Progression-free Survival
PFS defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as an increase in the sum of the longest diameters of ≥ 20% and an absolute increase in the sum of the longest diameters of ≥ 5 mm, or the appearance of a new lesion.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years 8 months.
Between 01May2013\&24Dec2014,209 patients were screened\&randomised from 87centres in Australia, Belgium,France, Germany, Israel, Italy, Korea, New Zealand, Portugal, Singapore, Spain,Taiwan \&the US. 209 patients randomized in the Intent to treat (ITT) population. 5 patients who did not receive study medication were not included in safety population.
| Milestone | mFOLFOX6 Plus SIRT | mFOLFOX6 Alone |
|---|---|---|
| Started | 105 | 104 |
| Completed | 35 | 35 |
| Not completed | 70 | 69 |
| Withdrew: Death | 58 | 64 |
| Withdrew: Withdrawal by subject | 8 | 4 |
| Withdrew: Adverse event | 2 | 0 |
| Withdrew: Lost to follow-up | 2 | 1 |
OS defined as the time interval between the date of randomization and the date of death from any cause.
| months | mFOLFOX6 Plus SIRT | mFOLFOX6 Alone |
|---|---|---|
| Overall Survival (OS) | 25.9 (23.1 to 29.0) | 25.0 (22.1 to 28.5) |
PFS defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as an increase in the sum of the longest diameters of ≥ 20% and an absolute increase in the sum of the longest diameters of ≥ 5 mm, or the appearance of a new lesion.
| months | mFOLFOX6 Plus SIRT | mFOLFOX6 Alone |
|---|---|---|
| Progression-free Survival | 11.8 (10.3 to 14.5) | 11.2 (9.4 to 12.6) |
Collected over From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| mFOLFOX6 Plus SIRT | 58/92 (63%) | 47/92 (51.1%) | 92/92 (100%) |
| mFOLFOX6 Alone | 64/112 (57.1%) | 47/112 (42%) | 111/112 (99.1%) |
| Event | mFOLFOX6 Plus SIRT | mFOLFOX6 Alone |
|---|---|---|
| Febrile NeutropeniaBlood and lymphatic system disorders | 10/92 | 3/112 |
| Abdominal PainGastrointestinal disorders | 9/92 | 0/112 |
| PneumoniaInfections and infestations | 6/92 | 3/112 |
| DiarrhoeaGastrointestinal disorders | 5/92 | 5/112 |
| Pulmonary EmbolismRespiratory, thoracic and mediastinal disorders | 5/92 | 0/112 |
| DehydrationMetabolism and nutrition disorders | 4/92 | 0/112 |
| PyrexiaGeneral disorders | 2/92 | 3/112 |
| NeutropeniaBlood and lymphatic system disorders | 2/92 | 1/112 |
| PancytopeniaBlood and lymphatic system disorders | 2/92 | 0/112 |
| Gastric UlcerGastrointestinal disorders | 2/92 | 0/112 |
| Event | mFOLFOX6 Plus SIRT | mFOLFOX6 Alone |
|---|---|---|
| Neuropathy peripheralNervous system disorders | 54/92 | 55/112 |
| DiarrhoeaGastrointestinal disorders | 35/92 | 59/112 |
| FatigueGeneral disorders | 48/92 | 49/112 |
| NauseaGastrointestinal disorders | 46/92 | 55/112 |
| NeutropeniaBlood and lymphatic system disorders | 43/92 | 46/112 |
| ThrombocytopeniaBlood and lymphatic system disorders | 39/92 | 11/112 |
| ConstipationGastrointestinal disorders | 39/92 | 45/112 |
| Abdominal PainGastrointestinal disorders | 33/92 | 24/112 |
| Weight DecreasedInvestigations | 29/92 | 19/112 |
| VomitingGastrointestinal disorders | 24/92 | 33/112 |
| Age, Continuous(years) | mFOLFOX6 Plus SIRT | mFOLFOX6 Alone | Total |
|---|---|---|---|
| Mean | 62.6 ± 11.28 | 62.4 ± 10.06 | 62.5 ± 10.66 |
| Age, Customized(Participants) | mFOLFOX6 Plus SIRT | mFOLFOX6 Alone | Total |
|---|---|---|---|
| Age, Categorical — Below 65 years | 60 | 57 | 117 |
| Age, Categorical — Greater than or equal to 65 years | 45 | 47 | 92 |
| Sex: Female, Male(Participants) | mFOLFOX6 Plus SIRT | mFOLFOX6 Alone | Total |
|---|---|---|---|
| Female | 41 | 44 | 85 |
| Male | 64 | 60 | 124 |
| Race (NIH/OMB)(Participants) | mFOLFOX6 Plus SIRT | mFOLFOX6 Alone | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 8 | 6 | 14 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 2 | 6 |
| White | 88 | 93 | 181 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 5 | 3 | 8 |
| WHO performance status(Participants) | mFOLFOX6 Plus SIRT | mFOLFOX6 Alone | Total |
|---|---|---|---|
| 0 | 61 | 53 | 114 |
| 1 | 44 | 50 | 94 |
| Unknown | 0 | 1 | 1 |
| Extra-hepatic Disease(participants) | mFOLFOX6 Plus SIRT | mFOLFOX6 Alone | Total |
|---|---|---|---|
| Yes | 32 | 27 | 59 |
| No | 73 | 77 | 150 |
| Liver Involvement %(participants) | mFOLFOX6 Plus SIRT | mFOLFOX6 Alone | Total |
|---|---|---|---|
| <=25% | 74 | 74 | 148 |
| >25% | 31 | 30 | 61 |
| Tumor volume(percentage of liver) | mFOLFOX6 Plus SIRT | mFOLFOX6 Alone | Total |
|---|---|---|---|
| Mean | 18.5 ± 17.77 | 17.9 ± 16.18 | 18.2 ± 16.96 |
1 further baseline measures are reported on the registry.
Plan to share: No
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sirtex Medical