Clinical trial · Interventional
A Study to See Whether Stereotactic Body RadioTherapy (SBRT) Can Shrink Tumours Within the Liver Safely
Stereotactic Body RadioTherapy (SBRT) for Oligo-metastatic Colo-rectal Cancer With Bio-marker Evaluation for Early Progression
NCT03175146CI-TRIAL-00028009unknownN/AClinicalTrials.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 proposed study will evaluate if "curative intent" SBRT can provide high response rates and clinically meaningful cancer control with acceptable toxicity specifically in patient with metastatic colorectal cancer (mCRC) who do not have surgical options and are no longer responding to systemic therapy
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Neoplasms | Colon Neoplasm | ALIAS | 0.90 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Body Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- Stereotactic Body Radiation Therapy
- interventionNames
- Radiation: Stereotactic Body Radiation Therapy
Primary outcomes (1)
- measure
- Response rate within the treated liver lesion
- timeFrame
- 6 months
- description
- RECIST Response
Secondary outcomes (5)
- measure
- Progression-free survival
- timeFrame
- Up to 5 years
- description
- Any progression of the disease
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed Colo-rectal Cancer * 1-3 Liver metastasis measurable on Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) * Surgically resected primary disease * Technically/medically inoperable or patient declined surgery * Progression or Stability after at least 1 Line of chemotherapy * Adequate marrow function: Hb \> 80g/L, Platelets \> 100 x 109/L, White blood cell \> 2 x 109/L * Eastern Cooperative Oncology Group (ECOG) status 0-2 * Age \> 18 years * Patient must sign study specific informed consent prior to study entry Exclusion Criteria: * Prior liver radiation, or radiation in close proximity to planned treatment sites * Prior invasive malignancy * Severe, active co-morbidity * Active hepatitis or Child Pugh Score B (9) or worse * Pregnant or nursing women * Extra hepatic disease: Any Bone/Any Brain, 2 or more Lung metastasis * Life expectancy \< 6 mo from any cause * Concurrent chemotherapy * Response to prior chemotherapy with minimal measurable disease in liver
References
Publications (0)
Data not yet available
No reference posted for this study.