Clinical trial · Interventional
A Trial on SBRT Versus MWA for Inoperable Colorectal Liver Metastases (CLM)
A Randomized Phase III Trial on Stereotactic Body Radiation Therapy (SBRT) Versus Microwave Ablation (MWA) for Inoperable Colorectal Liver Metastases (CLM)
NCT02820194CI-TRIAL-00060887terminatedN/AClinicalTrials.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): not sufficient patient recruited
Summary
Brief summary (as posted)
The trial is designed to perform a rigorous evaluation of efficacy and tolerability of SBRT by means of a randomised, controlled trial in patients affected by inoperable colorectal liver metastases. The chosen comparator is MWA. The two modality treatments (SBRT versus MWA) will be evaluated for short- and longer-term outcomes.
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 |
|---|---|---|---|
| Secondary Malignant Neoplasm of Liver | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Microwave Ablation | Procedure | — | UNRESOLVED |
| Stereotactic Body Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Stereotactic body radiation therapy
- description
- Patients are treated with Stereotactic Body Radiation Therapy, a methodology for delivering a conformal high dose of radiation to the tumor and a minimal dose to surrounding critical tissues, with a hypofractionation schedule.
- interventionNames
- Radiation: Stereotactic Body Radiation Therapy
- type
- ACTIVE_COMPARATOR
- label
- Microwave Ablation
- description
- Patients are treated with Microwave Ablation,a newer technology that utilizes high-frequency electromagnetic radiation to create thermal damage and coagulation necrosis.
- interventionNames
- Procedure: Microwave Ablation
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18 years * Karnofsky index \>70% * Histological proven adenocarcinoma of the colon or rectum with radiological (by CT- or MRI) or histological-/cytological verified liver metastases. * Metastases must be visible on diagnostic- and dose planning CT scans and on ultrasonography. * The patient should not be suitable for surgical resection due to technical or patient-related conditions. Resectability must be judged by a trained hepatobiliary surgeon and discussed in a multidisciplinary team meeting. * Presence of 1-3 lesions . * Diameter ≤ 40 mm. * All tumors should be feasible for treatment with each of the two modalities, SBRT and MWA * Adequate liver function: bilirubin \<1.5 mg/dl, alb\> 3.5g/dl, normal PT/PTT except if the patient uses anticoagulants, liver enzymes\<3 times upper limit of normal. No ascites. * Renal function must be adequate for infusion of iv. contrast for CT-scan. * Adequate bone marrow function: Hbg³8 g/dl, platelets³100.000 and leucocytes ³2.000/ml. * Informed consent. * Extrahepatic disease stable or in response after CT * No previous abdominal radiation therapy (RT) Exclusion Criteria: * Uncontrolled primary tumor or extrahepatic disease * Previous abdominal radiation therapy (RT) or other local conservative treatment on lesion target. * Pregnant or breastfeeding patients. * Prior malignancy within the last five years (except adequately treated basal cell carcinoma of the skin or in situ carcinoma of the skin or in situ carcinoma of the cervix, surgically cured, or localized prostate cancer without evidence of biochemical progression). * Previous inclusion in this study. * Underlying liver cirrhosis (Child-Pugh grade B or C). * Ascites and/or relevant intra-hepatic biliary tract dilatation. * Mental conditions rendering the patient incapable to understand the nature, scope, and consequences of the study.
References
Publications (0)
Data not yet available
No reference posted for this study.