An interventional study of TheraSphere in Colorectal Cancer Metastatic, sponsored by Boston Scientific Corporation. Completed at 131 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-29.
Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Treatment
The effectiveness and safety of TheraSphere will be evaluated in patients with colorectal cancer with metastases in the liver, who are scheduled to receive second line chemotherapy. All patients receive the standard of care chemotherapy with or without the addition of TheraSphere.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 428 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Standard of care second-line chemotherapy plus TheraSphere
Device: TheraSphere
Standard of care second-line chemotherapy with no added therapy
yttrium 90 microspheres
Progression Free Survival
Progression Free survival by blinded independent central review per RECIST 1.1
Time frame: From date of randomization until the date of first documented progression, as defined by RECIST 1:1 or date of death from any cause, whichever comes first, assessed up to a minimum of 1 year follow up or until study completion
Hepatic Progression-Free Survival (HPFS)
Hepatic Progression Free Survival (HPFS) by blinded independant central review per RECIST 1.1
Time frame: Time from randomization until hepatic PD by BICR per RECIST 1.1 or death, whichever occurs first, assessed up to a minimum of 1 year follow up or study completion.
Overall Survival
Time from randomization until date of death due to any cause as reported by study site.
Time frame: Time from date of randomization until date of death due to any cause; patients remaining on study post progression were followed until study completion; duration of follow up could be a few months to several years depending on when event was met.
| Milestone | Treatment Group | Control Group |
|---|---|---|
| Started | 215 | 213 |
| Completed | 169 | 153 |
| Not completed | 46 | 60 |
| Withdrew: Administrative reasons | 2 | 1 |
| Withdrew: Withdrawal by subject | 21 | 32 |
| Withdrew: Discontinuation by investigator or sponsor for any reason | 22 | 24 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
Progression Free survival by blinded independent central review per RECIST 1.1
| Months | Treatment Group | Control Group |
|---|---|---|
| Progression Free Survival | 8.0 (7.2 to 9.2) | 7.2 (5.7 to 7.6) |
Hepatic Progression Free Survival (HPFS) by blinded independant central review per RECIST 1.1
| Months | Treatment Group | Control Group |
|---|---|---|
| Hepatic Progression-Free Survival (HPFS) | 9.1 (7.8 to 9.7) | 7.2 (5.7 to 7.6) |
Time from randomization until date of death due to any cause as reported by study site.
| Months | Treatment Group | Control Group |
|---|---|---|
| Overall Survival | 14 (11.8 to 15.5) | 14.4 (12.8 to 16.4) |
Collected over AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Group | 182/215 (84.7%) | 95/187 (50.8%) | 186/187 (99.5%) |
| Control Group | 165/213 (77.5%) | 47/207 (22.7%) | 196/207 (94.7%) |
| Event | Treatment Group | Control Group |
|---|---|---|
| AscitesGastrointestinal disorders | 11/187 | 1/207 |
| Abdominal painGastrointestinal disorders | 10/187 | 4/207 |
| Febrile NeutropeniaBlood and lymphatic system disorders | 8/187 | 3/207 |
| Radiation hepatitisInjury, poisoning and procedural complications | 7/187 | 0/207 |
| PyrexiaGeneral disorders | 6/187 | 2/207 |
| DiarrhoeaGastrointestinal disorders | 4/187 | 5/207 |
| NeutropeniaBlood and lymphatic system disorders | 4/187 | 3/207 |
| VomitingGastrointestinal disorders | 4/187 | 1/207 |
| Colonic obstructionGastrointestinal disorders | 4/187 | 0/207 |
| CholecystitisHepatobiliary disorders | 4/187 | 0/207 |
| Event | Treatment Group | Control Group |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 62/187 | 102/207 |
| FatigueGeneral disorders | 91/187 | 94/207 |
| NauseaGastrointestinal disorders | 90/187 | 90/207 |
| Abdominal painGastrointestinal disorders | 68/187 | 41/207 |
| NeutropeniaBlood and lymphatic system disorders | 64/187 | 50/207 |
| ConstipationGastrointestinal disorders | 63/187 | 49/207 |
| decreased appetiteMetabolism and nutrition disorders | 51/187 | 47/207 |
| VomitingGastrointestinal disorders | 48/187 | 35/207 |
| PyrexiaGastrointestinal disorders | 40/187 | 21/207 |
| alopeciaSkin and subcutaneous tissue disorders | 23/187 | 43/207 |
| Age, Categorical(Participants) | Treatment Group | Control Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 126 | 132 | 258 |
| >=65 years | 89 | 81 | 170 |
| Sex: Female, Male(Participants) | Treatment Group | Control Group | Total |
|---|---|---|---|
| Female | 80 | 75 | 155 |
| Male | 135 | 138 | 273 |
| Race/Ethnicity, Customized(Participants) | Treatment Group | Control Group | Total |
|---|---|---|---|
| White or Caucasian | 164 | 169 | 333 |
| Black or African American | 9 | 8 | 17 |
| Asian | 25 | 17 | 42 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Other | 1 | 1 | 2 |
| Missing | 15 | 18 | 33 |
| Region of Enrollment(participants) | Treatment Group | Control Group | Total |
|---|---|---|---|
| Singapore | 5 | 2 | 7 |
| United States | 54 | 50 | 104 |
| United Kingdom | 52 | 75 | 127 |
| Spain | 22 | 17 | 39 |
| Canada | 9 | 6 | 15 |
| Austria | 0 | 2 | 2 |
| South Korea | 13 | 9 | 22 |
| Belgium | 4 | 0 | 4 |
| Hong Kong | 3 | 1 | 4 |
| Poland | 28 | 28 | 56 |
| France | 15 | 18 | 33 |
| Germany | 10 | 5 | 15 |
| Baseline Characteristics(Participants) | Treatment Group | Control Group | Total |
|---|---|---|---|
| ECOG 0 at baseline | 119 | 133 | 252 |
| ECOG 1 at baseline | 95 | 78 | 173 |
| KRAS status(Participants) | Treatment Group | Control Group | Total |
|---|---|---|---|
| KRAS mutant | 100 | 101 | 201 |
| KRAS wildtype | 115 | 112 | 227 |
| Unilobar vs Bilobar disease at baseline(Participants) | Treatment Group | Control Group | Total |
|---|---|---|---|
| unilobar | 39 | 40 | 79 |
| bilobar | 176 | 173 | 349 |
Showing the first 100 of 131 sites across 13 countries.
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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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