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Non-interventional Observational Study of Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Cancer

Non-interventional Observational Study of Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Cancer

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02228356
Enrollment
50
Registered
2014-08-29
Start date
2012-06-30
Completion date
Unknown
Last updated
2016-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasm Metastasis

Keywords

Neoplasm Metastasis, oligometastatic cancer, Stereotactic Body Radiation Therapy, SBRT, Real-time Tumor Tracking (RTTT), ITV, Internal Target Volume, Respiratory Motion Management, Image-guided Radiotherapy, IGRT

Brief summary

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.

Interventions

RADIATIONStereotactic Body Radiation Therapy

Stereotactic Body Radiation Therapy with either Dynamic Tumor Tracking/Internal Target Volume approach on the Vero machine, and/or Internal Target Volume approach on the Tomotherapy machine.

Sponsors

Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
One year local controlone year post radiotherapy

Secondary

MeasureTime frameDescription
Acute toxicityUp to 3 months post radiotherapy
Survival3 to 36 months post RadiotherapyOverall survival
Progression Free Survival3 to 36 months post Radiotherapy
Late toxicity3 to 36 months post Radiotherapy

Countries

Belgium

Contacts

Primary ContactBenedikt Engels, MD, PhD
benedikt.engels@uzbrussel.be+324776041
Backup ContactCleo Wauters, MD
cleo.wauters@uzbrussel.be+324776041

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026