Clinical trial · Interventional
A Pilot Study of Individualized Adaptive Radiation Therapy for Hepatocellular Carcinoma
- 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 pilot single arm study with the primary endpoints of feasibility and preliminary estimates of safety and efficacy. This protocol builds on over 25 years of experience with high dose liver RT (Radiation Therapy), and in particular adaptive RT aimed at adjusting the global radiation dose based on a patient's measured sensitivity to treatment. This current protocol uses functional imaging and specialized radiation planning techniques to spare highly functional portions of the liver to preserve function. The investigators feel this will further improve the safety and efficacy of RT for all patients by customizing treatments to each. If this approach is promising, the investigators will proceed to a phase II randomized study of standard versus spatially and dosimetrically adapted RT.
Conditions
Conditions (1)
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 Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adaptive Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Adaptive Radiation Therapy
- interventionNames
- Radiation: Adaptive Radiation Therapy
Primary outcomes (3)
- measure
- The Proportion of Patients for Whom the Intended Treatment Was Feasible
- timeFrame
- At end of treatment; up to ~3 months
- description
- The primary aim of the trial is feasibility which is defined as the ability to successfully deliver the full treatment including all adaptations and in particular the perfusion-based planning and replanning.
- measure
- Percentage of Patients With Change in Child Pugh Score >= 2
- timeFrame
- Baseline to approximately 6 months after initiation of SBRT
- description
- Rate of liver decompensation reported as the percentage of patients with a change in Child Pugh score of greater than or equal to 2 within 6 months of SBRT.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have hepatocellular carcinoma. * Patients must not have extrahepatic cancer. * Patients must not be eligible for a curative liver resection or have refused resection * Patients must have recovered from the acute effects of prior liver-directed therapy and 4 weeks must have passed since the last procedure and protocol therapy. * Patients must have a Zubrod performance status of less than or equal to 2 (Zubrod performance status is a measure that attempts to quantify a cancer patients' general well-being. Scores run from 0 to 5 where 0 denotes normal activity and 5 denotes death). * Patients must be 18 years of age or older. * Patients must have adequate organ function. * Patients must understand and be willing to sign an IRB (Institutional Review Board) approved informed consent form. Exclusion Criteria: * Patients with known allergies to intravenous iodinated contrast agents. * Patients with a contraindication to contrast-enhanced MRI are excluded.
References
Publications (0)
Data not yet available