Clinical trial · Interventional
Stereotaxic Irradiation of Hepatocellular Carcinoma
Stereotaxic Irradiation of Hepatocellular Carcinoma : Phase II Study
NCT01165346CI-TRIAL-00105448CKNO-HEPcompletedPhase 2ClinicalTrials.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)
Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days for a total of 45 Gy.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CyberKnife | Radiation | — | UNRESOLVED |
| Fiducials | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stereotaxic radiation by CyberKnife
- description
- Implantation of fiducials Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days
- interventionNames
- Radiation: Fiducials
- Radiation: CyberKnife
Primary outcomes (1)
- measure
- non-progression part
- timeFrame
- Up to 18 months
- description
- Percentage of non-progression 18 months after treatment, according to RECIST criteria
Secondary outcomes (8)
- measure
- acute and late tolerance
- timeFrame
- Up to 5 years after treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Primitive liver cancer (hepatocellular carcinoma), proved by histology or diagnostic according to BCLC criteria * T1-3 N0 M0 * With only one intra hepatic lesion and dimensions between 1 cm and 6 cm (IRM or hepatic scanner) * Stereotaxic radiotherapy treatment approved in multidisciplinary consultation, the patient being rejected for standard therapeutic * Age \>= 18 ans * Previous anti tumoral treatment allowed but suspended since at least 15 days before the inclusion * OMS =\< 2 * Portal thrombosis allowed * Portal high blood pressure allowed * No contraindication of fiducials implantation, hemostasis disorders must be treated before the implantation * In case of underlying cirrhosis, only the Child-Pugh A is allowed * Life expectancy \>= 12 weeks * Women must have an active contraception during all the study * Patient affiliated to health insurance * Patient must sign the consent Exclusion Criteria: * T4 * Cirrhosis Child B and C * Hepatic lesion \< 1 cm or \> 6 cm * 2 hepatic lesions or more * Recurrent or metastatic disease * Patient already included in another therapeutic trial with an experimental molecule * Allergy to gold * Pregnant women or susceptible to be pregnant or breastfeeding * Unable for medical follow-up (geographic, social or mental reasons)
References
Publications (0)
Data not yet available
No reference posted for this study.