Clinical trial · Interventional
Radiation Dose Escalation Study for Advanced Liver Cancer
Phase I Trial of Radiation Dose Escalation for Locally Advanced Hepatocellular Carcinoma
NCT00848094CI-TRIAL-00002077completedPhase 1ClinicalTrials.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)
The purpose of this clinical study is to determine the maximum tolerated dose (MTD) of 3-dimensional conformal radiation therapy (3-DCRT)/intensity modulated radiation therapy (IMRT) for locally advanced hepatocellular carcinoma (HCC).
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 |
|---|---|---|---|
| 3DCRT/IMRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- arm 1
- description
- Arm I: tumor diameter more than 5 cm and less than 10 cm.
- interventionNames
- Radiation: 3DCRT/IMRT
- type
- OTHER
- label
- arm 2
- description
- Arm II: tumor diameter no less than 10 cm.
- interventionNames
- Radiation: 3DCRT/IMRT
Primary outcomes (1)
- measure
- Toxicity was graded using the CTCAE 3.0. Dose-limiting toxicity was defined as acute ≥ grade 3 hepatic or gastrointestinal toxicity, or any grade 5 treatment-related adverse event, or late complication of radiation-induced liver disease.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed or clinically diagnosed HCC * Surgically unsectable or medically inoperable diseases, or surgery declined by the patient * Solitary intrahepatic lesion with diameter bigger than 5 cm, without extrahepatic and/or distant metastases * Associated with cirrhosis of Child-Pugh A * Karnofsky performance status (KPS) of ≥ 70 * Normal renal function and adequate bone marrow reservation * Tolerate active breathing control (ABC) Exclusion Criteria: * Child-Pugh B or C liver cirrhosis score * Previous radiotherapy to the liver * Indistinct tumor boundary in CT/MRI image
References
Publications (0)
Data not yet available
No reference posted for this study.