Clinical trial · Observational
Non-interventional Observational Study of Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Cancer
- 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 investigators recently published 2 phase II trials on the use of helical tomotherapy for oligometastatic colorectal cancer \[1,2\]. Despite a dose increase from 40 to 50 Gy, delivered in 2 weeks time, the one-year local control was 54% only \[1,2\]. The high local failure rate is probably the result of geographical misses due to tumor motion and a biologically effective dose (BED) of \< 100 Gy. The current study will investigate whether the one-year local control rate can be improved to 70%, using respiration correlated CT to individualize the margin needed to account for tumor motion, to avoid geographical miss, together with a Monte Carlo or collapsed cone dose calculation algorithm delivering 50 Gy to the 80% isodose, allowing higher doses in the tumor core. As the concept of an internal target volume (ITV) may result in large margins for patients displaying metastases in high mobile organs, such as liver and lung, which may lead to exposure of a relatively high dose to a large volume of normal tissue, dynamic tumor tracking by the VERO SBRT system will be applied in those patients.
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 |
|---|---|---|---|
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Body Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- One year local control
- timeFrame
- one year post radiotherapy
Secondary outcomes (4)
- measure
- Acute toxicity
- timeFrame
- Up to 3 months post radiotherapy
- measure
- Survival
- timeFrame
- 3 to 36 months post Radiotherapy
- description
- Overall survival
- measure
- Progression Free Survival
- timeFrame
- 3 to 36 months post Radiotherapy
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with metastatic cancer from any primary origin and no more than 5 metastases on CT--scan 2. Primary tumor treated with curative intention (surgery, radiotherapy, chemoradiotherapy) 3. Functional liver volume \> 1000cc in case of liver metastases and a lung diffusion capacity for carbon monoxide (DLCO) of \> 30% if lung mets 4. No Child B or C liver cirrhosis 5. No systemic treatment within 1 month before initiation of radiotherapy 6. No contra-indications for radiation of all metastatic disease (= no violation of constraints of organs at risk (OAR)) 7. No metastases from another carcinoma 8. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 9. Age \> 18 years
References
Publications (2)
- BACKGROUNDEngels B, Everaert H, Gevaert T, Duchateau M, Neyns B, Sermeus A, Tournel K, Verellen D, Storme G, De Ridder M. Phase II study of helical tomotherapy for oligometastatic colorectal cancer. Ann Oncol. 2011 Feb;22(2):362-8. doi: 10.1093/annonc/mdq385. Epub 2010 Aug 4. PMID 20685718
- BACKGROUNDEngels B, Gevaert T, Everaert H, De Coninck P, Sermeus A, Christian N, Storme G, Verellen D, De Ridder M. Phase II study of helical tomotherapy in the multidisciplinary treatment of oligometastatic colorectal cancer. Radiat Oncol. 2012 Mar 16;7:34. doi: 10.1186/1748-717X-7-34. PMID 22423615