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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

Tracking Information
First Submitted Date August 22, 2014
First Posted Date August 29, 2014
Last Update Posted Date May 11, 2016
Study Start Date June 2012
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 26, 2014)
One year local control [ Time Frame: one year post radiotherapy ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02228356 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 26, 2014)
  • Acute toxicity [ Time Frame: Up to 3 months post radiotherapy ]
  • Survival [ Time Frame: 3 to 36 months post Radiotherapy ]
    Overall survival
  • Progression Free Survival [ Time Frame: 3 to 36 months post Radiotherapy ]
  • Late toxicity [ Time Frame: 3 to 36 months post Radiotherapy ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Non-interventional Observational Study of Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Cancer
Official Title Non-interventional Observational Study of Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Cancer
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with metastatic cancer from any primary origin and no more than 5 metastases.
Condition Neoplasm Metastasis
Intervention 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
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August 26, 2014)
50
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT02228356
Other Study ID Numbers BUN143201215117
BUN143201215117 ( Registry Identifier: UZ Brussel Ethics Committee )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Benedikt Engels, MD, PhD, Universitair Ziekenhuis Brussel
Study Sponsor Universitair Ziekenhuis Brussel
Collaborators Not Provided
Investigators
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
PRS Account Universitair Ziekenhuis Brussel
Verification Date May 2016