Neoplasm MetastasisNCT02228356
Non-interventional Observational Study of Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Cancer
An observational study of Neoplasm Metastasis, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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]. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Neoplasm Metastasis
- What is being tested?
- Stereotactic Body Radiation Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2012to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic cancer from any primary origin and no more than 5 metastases.
Who may be able to join
- Patients with metastatic cancer from any primary origin and no more than 5 metastases on CT--scan
- Primary tumor treated with curative intention (surgery, radiotherapy, chemoradiotherapy)
- Functional liver volume > 1000cc in case of liver metastases and a lung diffusion capacity for carbon monoxide (DLCO) of > 30% if lung mets
- No Child B or C liver cirrhosis
- No systemic treatment within 1 month before initiation of radiotherapy
- No contra-indications for radiation of all metastatic disease (= no violation of constraints of organs at risk (OAR))
Show all 9Show fewer
- No metastases from another carcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Age > 18 years
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Brussel Radiotherapie dienst
Jette, Brussels Capital, 1090
Benedikt Engels, MD, PhD
Mark De Ridder, MD, PhD
About this study
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
- Neoplasm Metastasis
- Being tested
- Stereotactic Body Radiation Therapy
- 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
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation TherapyRadiation
Also called Vero, Tomotherapy
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
One year local control
Measured: one year post radiotherapy
Secondary outcomes (4)
Acute toxicity
Measured: Up to 3 months post radiotherapy
Survival
Overall survival
Measured: 3 to 36 months post Radiotherapy
Progression Free Survival
Measured: 3 to 36 months post Radiotherapy
Late toxicity
Measured: 3 to 36 months post Radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study startJun 2012
- Primary completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neoplasm MetastasisStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benedikt Engels, MD, PhD, Universitair Ziekenhuis Brussel
- Investigators
- Benedikt Engels, MD, PhD, Principal investigator, Dienst Radiotherapie, UZ Brussel, Vrije Universiteit BrusselRobbe Van den Begin, MD, Principal investigator, Dienst Radiotherapie, UZ Brussel, Vrije Universiteit BrusselMark De Ridder, MD, PhD, Principal investigator, Dienst Radiotherapie, UZ Brussel, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228356
- Sponsor's protocol ID
- BUN143201215117
- Other IDs
- BUN143201215117
- Status last verified
- May 2016
- First submitted
- 22 Aug 2014
- Last updated
- 11 May 2016
- Results posted
- No
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 20685718Engels 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
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Observational Study of Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Cancer
- ClinicalTrials.gov ID
- NCT02228356
- Acronym / sponsor ID
- BUN143201215117
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2017 (estimated)
- First posted
- 29 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic cancer from any primary origin and no more than 5 metastases.
Key inclusion criteria (9 listed)
- Patients with metastatic cancer from any primary origin and no more than 5 metastases on CT--scan
- Primary tumor treated with curative intention (surgery, radiotherapy, chemoradiotherapy)
- Functional liver volume > 1000cc in case of liver metastases and a lung diffusion capacity for carbon monoxide (DLCO) of > 30% if lung mets
- No Child B or C liver cirrhosis
- No systemic treatment within 1 month before initiation of radiotherapy
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Body Radiation TherapyAlso: Vero, TomotherapyStereotactic 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. | Radiation | – |
Primary outcome
One year local control
Time frame: one year post radiotherapy
4 secondary outcomes
Acute toxicity
Time frame: Up to 3 months post radiotherapy
Survival
Time frame: 3 to 36 months post Radiotherapy
Progression Free Survival
Time frame: 3 to 36 months post Radiotherapy
Late toxicity
Time frame: 3 to 36 months post Radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
- Background: PubMed 20685718Engels 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.
- Background: PubMed 22423615Engels 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasm Metastasis, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benedikt Engels, MD, PhD (+324776041, benedikt.engels@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One year local control (time frame: one year post radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02228356, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2016.