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Transarterial Chemoembolization Compared With Stereotactic Body Radiation Therapy or Stereotactic Ablative Radiation Therapy in Treating Patients With Residual or Recurrent Liver Cancer Undergone Initial Transarterial Chemoembolization
Phase 3 trial testing Stereotactic Body Radiation Therapy in Child-Pugh Class A in 13 participants. Terminated before completion.
| Lead sponsor | Stanford University |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 13 |
| Start date | 27 February 2016 |
| Primary completion | 31 December 2022 |
| Estimated completion | 31 December 2022 |
| Sites | 2 locations across Japan, United States |
Stanford University
18 and older, any sex, with Child-Pugh Class A or Child-Pugh Class B. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Local progression event: occurring in the treated hepatic lesion.
| Group | Value | 95% CI |
|---|---|---|
| Transarterial Chemoembolization (TACE) | 0 | |
| Stereotactic Body Radiation Therapy (SBRT) | 0 |
The time to freedom from extra hepatic progression will be estimated by competing risk models with death as a competing risk. Risk factors such as tumor size and institution will be tested in a multivariate Cox regression model adjusting for the competing risks.
| Group | Value | 95% CI |
|---|---|---|
| Transarterial Chemoembolization (TACE) | NA | NA – NA |
| Stereotactic Body Radiation Therapy (SBRT) | NA | NA – NA |
Extra hepatic PFS within each subgroup will be summarized by cumulative incidence function estimators adjusted for the competing risk of death or regional or distant progression.
| Group | Value | 95% CI |
|---|---|---|
| Transarterial Chemoembolization (TACE) | NA | NA – NA |
| Stereotactic Body Radiation Therapy (SBRT) | NA | NA – NA |
FFLP within each subgroup will be summarized by cumulative incidence function estimators adjusted for the competing risk of death or regional or distant progression.
| Group | Value | 95% CI |
|---|---|---|
| Transarterial Chemoembolization (TACE) | NA | NA – NA |
| Stereotactic Body Radiation Therapy (SBRT) | NA | NA – NA |
Overall survival will be summarized using Kaplan-Meier curves and medians with 95% confidence intervals calculated using Greenwood's formula. Log rank tests will be used to compare treatment groups. Cox proportional hazard models will be used to estimate hazard ratios between treatment groups and to assess other risk factors, in particular the effect of tumor size and the impact of the different institutions.
| Group | Value | 95% CI |
|---|---|---|
| Transarterial Chemoembolization (TACE) | NA | NA – NA |
| Stereotactic Body Radiation Therapy (SBRT) | NA | NA – NA |
Within each subgroup OS will be summarized using Kaplan-Meier curves and medians with 95% confidence intervals calculated using Greenwood's formula.
| Group | Value | 95% CI |
|---|---|---|
| Transarterial Chemoembolization (TACE) | NA | NA – NA |
| Stereotactic Body Radiation Therapy (SBRT) | NA | NA – NA |
Including local, regional, or distant progression events, or death. Local progression event: occurring in the treated tumor. Regional progression event: occurring in the same part of the body as the treated tumor. Distant progression event: occurring outside the region of the body where the treated tumor is located.
| Group | Value | 95% CI |
|---|---|---|
| Transarterial Chemoembolization (TACE) | 1 | |
| Stereotactic Body Radiation Therapy (SBRT) | 3 |
Including local, regional, or distant progression events, or death. Local progression event: occurring in the treated tumor. Regional progression event: occurring in the same part of the body as the treated tumor. Distant progression event: occurring outside the region of the body where the treated tumor is located.
| Group | Value | 95% CI |
|---|---|---|
| Transarterial Chemoembolization (TACE) | 1 | |
| Stereotactic Body Radiation Therapy (SBRT) | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | 1 |
The impact of elevated AFP level on time to event endpoints will be evaluated both in terms of the initial AFP level and on-study levels in a Cox proportional hazards model.
| Group | Value | 95% CI |
|---|---|---|
| Transarterial Chemoembolization (TACE) | NA | NA – NA |
| Stereotactic Body Radiation Therapy (SBRT) | NA | NA – NA |
The impact of elevated AFP level on time to event endpoints will be evaluated both in terms of the initial AFP level and on-study levels in a Cox proportional hazards model.
| Group | Value | 95% CI |
|---|---|---|
| Transarterial Chemoembolization (TACE) | NA | NA – NA |
| Stereotactic Body Radiation Therapy (SBRT) | NA | NA – NA |
The impact of elevated AFP level on time to event endpoints: FFLP, PFS, extra hepatic PFS and OS will be evaluated both in terms of the initial AFP level and on-study levels in a Cox proportional hazards model.
| Group | Value | 95% CI |
|---|---|---|
| Transarterial Chemoembolization (TACE) | NA | NA – NA |
| Stereotactic Body Radiation Therapy (SBRT) | NA | NA – NA |
The impact of elevated AFP level on time to event endpoints will be evaluated both in terms of the initial AFP level and on-study levels in a Cox proportional hazards model.
| Group | Value | 95% CI |
|---|---|---|
| Transarterial Chemoembolization (TACE) | NA | NA – NA |
| Stereotactic Body Radiation Therapy (SBRT) | NA | NA – NA |
Time frame: Up to 3 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Transarterial Chemoemboliz… | Stereotactic Body Radiatio… |
|---|---|---|---|
| Cholecystitis | Hepatobiliary disorders | — | — |
| Reaction | System | Transarterial Chemoemboliz… | Stereotactic Body Radiatio… |
|---|---|---|---|
| Platelet count decreased | Investigations | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| AST increased | Investigations | — | — |
| Blood Bilirubin increased | Investigations | — | — |
| Fatigue | General disorders | — | — |
| Abdominal Pain | Gastrointestinal disorders | — | — |
| Ascites | Gastrointestinal disorders | — | — |
| Alkaline phosphatase increased | Investigations | — | — |
| Alkaline Phosphatase increased | Investigations | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| Neutrophil count decreased | Investigations | — | — |
| WBC decreased | Investigations | — | — |
| Hypocalcemia | Metabolism and nutrition disorders | — | — |
| Bloating | Gastrointestinal disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| GI disorder other | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Bile duct stenosis | Hepatobiliary disorders | — | — |
| Hepatic Pain | Hepatobiliary disorders | — | — |
| Portal Hypertension | Hepatobiliary disorders | — | — |
| ALT | Investigations | — | — |
| Creatinine increased | Investigations | — | — |
| INR increased | Investigations | — | — |
| Investigations | — | — | |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — |
| Hypertension | Vascular disorders | — | — |
Most-reported serious reactions: Cholecystitis.
Data from ClinicalTrials.gov NCT02762266 adverse events section.
This randomized phase III trial studies how well transarterial chemoembolization (TACE) works compared to stereotactic body radiation therapy (SBRT) or stereotactic ablative radiation therapy (SABR) in patients with liver cancer that remain after attempts to remove the cancer have been made (residual) or has come back (recurrent). TACE is a minimally invasive, image-guided treatment procedure that uses a catheter to deliver both chemotherapy medication and embolization materials into the blood vessels that lead to the tumors. SBRT or SABR may be able to send radiation directly to the tumor and cause less damage to normal liver tissue. It is not yet known whether TACE is more effective than SBRT or SABR in treating patients with persistent or recurrent liver cancer who have undergone initial TACE.
5 peer-reviewed publications reference this trial (live from Europe PMC):
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