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

• Conditions: Neoplasm Metastasis

• Registration Number: NCT02228356
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2014-08-22
• Study First Submitted QC: 2014-08-26
• Study First Posted: 2014-08-29
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-11
• Primary Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
One year local control	one year post radiotherapy

Secondary Outcome Measures

Name	Time	Method
Acute toxicity	Up to 3 months post radiotherapy
Survival	3 to 36 months post Radiotherapy	Overall survival
Progression Free Survival	3 to 36 months post Radiotherapy
Late toxicity	3 to 36 months post Radiotherapy

Trial Locations

Locations (1)

UZ Brussel Radiotherapie dienst; 🇧🇪 Jette, Brussel, Belgium