Clinical trial · Interventional
CyberKnife® for Hepatic Metastases From Colorectal Cancer
International, Phase II Study of CyberKnife® for Hepatic Metastases From Colorectal Cancer
NCT01318447CI-TRIAL-00009939terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of enrollment
Summary
Brief summary (as posted)
This prospective, multicenter study is intended to establish the efficacy and toxicity of treating unresectable colorectal liver metastases with accurately administered radiation using the CyberKnife stereotactic radiosurgery system.
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 |
|---|---|---|---|
| Colorectal Liver Metastases | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CyberKnife SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CyberKnife SBRT
- interventionNames
- Radiation: CyberKnife SBRT
Primary outcomes (1)
- measure
- Local recurrence-free survival
- timeFrame
- 12 months
- description
- Local hepatic control (non progression: complete response, partial response or stable disease) will be assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Local recurrence-free survival time is calculated as the time between the date of first treatment session and the date of the first local recurrence. Patients alive who never experienced local recurrence at the time of analysis are censored at the date of the last follow-up visit. Patients who die from causes other than local recurrence at the time of analysis are censored at the date of death.
Secondary outcomes (6)
- measure
- Recurrence-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or Female * Hepatic metastases from histologically confirmed colorectal adenocarcinoma * 3 hepatic lesions or less present * Cumulative size of hepatic lesions between 1 and 10 cm * Treatment determined by the liver/GI tumor board or equivalent organization at the participating site * Metastatic disease not amenable to surgery as assessed by the panel (including a surgeon) or patient who refuses surgery * Patient must be able to undergo contrast enhanced CT for planning * Age \>= 18 years old * Performance Status (ECOG) ≤ 2 * Minimum of 6 months between the initial diagnosis of the disease and the first hepatic metastasis * Minimum of 4 weeks between prior chemotherapy or targeted therapy and the first CyberKnife session * Total bilirubin ≤ 3 times the upper limit of normal, ASAT and ALAT ≤ 5 times the upper limit of normal * Albumin \>= 36 g/L and lymphocytes \>= 700/mm3 * No contraindication to fiducials implantation, hemostasis problems shall be corrected before implantation * Life expectancy \>= 3 months * Patient affiliated with a health insurance system. Applicable for French patients only. * Patient having signed the informed consent Exclusion Criteria: * Prior abdominal radiation therapy * Any evidence of visible intra-hepatic bile duct dilatation on pre-treatment images * Extrahepatic metastases * Current evidence of ascitis * Renal insufficiency (creatinine clearance \< 45 ml/min) * Known allergy to gold * Pregnant or lactating woman * Prior history of other cancer except basocellular carcinoma and in situ cervix carcinoma * Patient already enrolled in another therapeutic clinical trial * Inability to comply with follow-up visits for geographical, social or psychological reasons
References
Publications (0)
Data not yet available
No reference posted for this study.