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

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ClinicalTrials.gov Identifier: NCT02228356
Recruitment Status : Unknown
Verified May 2016 by Benedikt Engels, MD, PhD, Universitair Ziekenhuis Brussel.
Recruitment status was:  Recruiting
First Posted : August 29, 2014
Last Update Posted : May 11, 2016
Sponsor:
Information provided by (Responsible Party):
Benedikt Engels, MD, PhD, 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.

Condition or disease Intervention/treatment
Neoplasm Metastasis Radiation: Stereotactic Body Radiation Therapy

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional Observational Study of Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Cancer
Study Start Date : June 2012
Estimated Primary Completion Date : June 2017

Intervention Details:
  • Radiation: Stereotactic 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.
    Other Names:
    • Vero
    • Tomotherapy


Primary Outcome Measures :
  1. One year local control [ Time Frame: one year post radiotherapy ]

Secondary Outcome Measures :
  1. Acute toxicity [ Time Frame: Up to 3 months post radiotherapy ]
  2. Survival [ Time Frame: 3 to 36 months post Radiotherapy ]
    Overall survival

  3. Progression Free Survival [ Time Frame: 3 to 36 months post Radiotherapy ]
  4. Late toxicity [ Time Frame: 3 to 36 months post Radiotherapy ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228356


Contacts
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Contact: Benedikt Engels, MD, PhD +324776041 benedikt.engels@uzbrussel.be
Contact: Cleo Wauters, MD +324776041 cleo.wauters@uzbrussel.be

Locations
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Belgium
UZ Brussel Radiotherapie dienst Recruiting
Jette, Brussel, Belgium, 1090
Principal Investigator: Benedikt Engels, MD, PhD         
Principal Investigator: Mark De Ridder, MD, PhD         
Principal Investigator: Robbe Van Den Begin, MD         
Sub-Investigator: Harijati Versmessen, MD         
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
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Principal Investigator: Benedikt Engels, MD, PhD Dienst Radiotherapie, UZ Brussel, Vrije Universiteit Brussel
Principal Investigator: Robbe Van den Begin, MD Dienst Radiotherapie, UZ Brussel, Vrije Universiteit Brussel
Principal Investigator: Mark De Ridder, MD, PhD Dienst Radiotherapie, UZ Brussel, Vrije Universiteit Brussel

Publications:
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Responsible Party: Benedikt Engels, MD, PhD, Radiation Oncologist, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT02228356     History of Changes
Other Study ID Numbers: BUN143201215117
BUN143201215117 ( Registry Identifier: UZ Brussel Ethics Committee )
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: May 2016
Keywords provided by Benedikt Engels, MD, PhD, Universitair Ziekenhuis Brussel:
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
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms
Neoplastic Processes
Pathologic Processes