Phase 2
Completed N=151
TheraSphere for the Treatment of Liver Metastases
Colorectal Cancer · Carcinoma, Neuroendocrine · Neoplasm Metastasis
Source: ClinicalTrials.gov NCT00511862 ↗
Enrolled (actual)
151
Serious AEs
13.9%
Results posted
May 2014
Primary outcomePrimary: Hepatic Progression-free Survival According to Response Evaluation Criterian in Solid Tumors (RECIST) — 3.0; 17.9; 2.9; 3.4 Months
Summary
This study will evaluate Liver Progression Free Survival (PFS) and safety of TheraSphere treatment at doses of 120 Gy +/1 10% in patients at least 18 years of age diagnosed with metastatic disease to the liver that cannot be treated or is progressing following treatment with systemic or other liver-directed therapies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hepatic Progression-free Survival According to Response Evaluation Criterian in Solid Tumors (RECIST) |
3.0; 17.9; 2.9; 3.4 | — |
| SECONDARY Overall Survival |
8.8; 10.4; 13.6 | — |
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- diagnosis of metastatic disease to the liver that is refractory to, or inappropriate for, other systemic or liver-directed therapies
- unresectable liver metastases
- target tumors measurable using standard imaging techniques
- tumor replacement 2.0 mg/dL unless on dialysis; serum bilirubin ≥ 2.0 mg/dL; albumin 30 Gy cumulative limit
- evidence on technetium-99m macroaggregated albumin scan showing potential for deposition of microspheres to the gastrointestinal tract that cannot be eliminated by catheter placement or corrective action using standard angiographic techniques
- positive serum pregnancy test in women of childbearing potential
- co-morbid disease or condition that puts the patient at undue risk or precludes use of TheraSphere in judgment of physician
Data sourced from ClinicalTrials.gov (NCT00511862). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.