Clinical trial · Interventional
A Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer
A Phase II Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer
NCT01522937CI-TRIAL-00026362completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase II trial to characterize the safety and efficacy of individualized stereotactic body radiation therapy (SRBT) for patients who have had previous liver treatment or who have primary hepatocellular carcinoma (HCC).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Cancer | Hepatocellular Carcinoma | CURATED_BROADER | 0.80 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| individualized Stereotactic Body Radiation Therapy (SBRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Liver cancer patients
- description
- The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).
- interventionNames
- Radiation: individualized Stereotactic Body Radiation Therapy (SBRT)
Primary outcomes (1)
- measure
- The Percentage of Patients With Local Control at 1 Year Post Treatment
- timeFrame
- 1 Year
- description
- For this study, local control is defined as the lack of progressive local disease following CR (Complete Response) or PR (Partial Response), or lack of progressive local disease in patients with non-evaluable disease, who have no progressive elevation in serum tumor markers.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * over age 18 * life expectancy of at least 12 weeks * Zubrod performance status of ≤2. * biopsy proven hepatocellular carcinoma (HCC) * liver metastases * a discrete hepatic tumor(s) as defined by the Barcelona46 criteria - for cirrhotic patients, (1) 2 imaging studies showing hypervascular tumor \> 2cm, or (2) single imaging study showing hypervascular tumor \> 2cm with AFP ≥ 400 ng/mL * a discrete hypervascular tumor present on two consecutive imaging studies (CT or MRI) with documented growth of \> 1cm in diameter * adequate organ function * women and men not interested in pregnancy * must be recovered from the effects of any prior surgery, radiation therapy, chemotherapy and the effects of Radiofrequency Ablation (RFA) or Transcatheter Arterial Chemo Embolization (TACE) * minimum of 6 weeks following their last surgical procedure, radiation and chemotherapy. Exclusion Criteria: * cannot be eligible for a curative liver resection * uncontrolled ascites clinically evident on physical exam * known allergy to IC-Green * known allergy to intravenous iodinated contrast agents * patients with poor venous access * patients with metastatic cancer with normal liver function who have not undergone previous liver directed therapy and a single tumor \< 6 cm in size.
References
Publications (1)
- DERIVEDFeng M, Suresh K, Schipper MJ, Bazzi L, Ben-Josef E, Matuszak MM, Parikh ND, Welling TH, Normolle D, Ten Haken RK, Lawrence TS. Individualized Adaptive Stereotactic Body Radiotherapy for Liver Tumors in Patients at High Risk for Liver Damage: A Phase 2 Clinical Trial. JAMA Oncol. 2018 Jan 1;4(1):40-47. doi: 10.1001/jamaoncol.2017.2303. PMID 28796864