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Status unknownNCT02228356Updated May 11, 2016

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

An observational study in Neoplasm Metastasis, sponsored by Universitair Ziekenhuis Brussel. Status unknown at 1 site in Belgium. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2016-05-11.

Sponsored by Universitair Ziekenhuis Brussel · Observational

The sponsor has not verified this record recently (last verified May 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Neoplasm Metastasis

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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
03

In context

Neoplasm Metastasis

3,562 studies on the registry are indexed under Neoplasm Metastasis; 875 are open to participants now.

This study's planned enrollment of 50 is below the median of 120 across 604 observational studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Universitair Ziekenhuis Brussel is the lead sponsor of 374 studies on the registry; 106 are open to participants now.

Browse Universitair Ziekenhuis Brussel studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with metastatic cancer from any primary origin and no more than 5 metastases.

Eligibility criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

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.

    Also known as: Vero, Tomotherapy

06

What researchers measure

Primary outcomes

  1. One year local control

    Time frame: one year post radiotherapy

Secondary outcomes

  1. Acute toxicity

    Time frame: Up to 3 months post radiotherapy

  2. Survival

    Overall survival

    Time frame: 3 to 36 months post Radiotherapy

  3. Progression Free Survival

    Time frame: 3 to 36 months post Radiotherapy

  4. Late toxicity

    Time frame: 3 to 36 months post Radiotherapy

07

Study locations

1 of 1 sites recruiting
  • UZ Brussel Radiotherapie dienst
    Jette, Brussels Capital 1090, Belgium
    • Benedikt Engels, MD, PhD · Principal investigator
    • Mark De Ridder, MD, PhD · Principal investigator
    • Robbe Van Den Begin, MD · Principal investigator
    • Harijati Versmessen, MD · Sub investigator
    Recruiting
08

References and documents

Publications

  • Engels 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. PubMed 20685718 ↗
  • Engels 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. PubMed 22423615 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2012 and a primary completion of Jun 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2014
First posted
Aug 29, 2014
Start
Jun 2012
Primary completionEst.
Jun 2017
Last update
May 11, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02228356
Lead sponsor
Universitair Ziekenhuis Brussel
Responsible party
Benedikt Engels, MD, PhD (Radiation Oncologist, Universitair Ziekenhuis Brussel) — Principal investigator
First posted
Aug 29, 2014
Start date
Jun 2012
Primary completion
Jun 2017 (estimated)
Last update
May 11, 2016

Study contacts

Benedikt Engels, MD, PhD
Contact
benedikt.engels@uzbrussel.be
+324776041
Cleo Wauters, MD
Contact
cleo.wauters@uzbrussel.be
+324776041
Benedikt Engels, MD, PhD
principal investigator · Dienst Radiotherapie, UZ Brussel, Vrije Universiteit Brussel
Robbe Van den Begin, MD
principal investigator · Dienst Radiotherapie, UZ Brussel, Vrije Universiteit Brussel
Mark De Ridder, MD, PhD
principal investigator · Dienst Radiotherapie, UZ Brussel, Vrije Universiteit Brussel
View the source record on ClinicalTrials.gov ↗

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