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

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 Overview

• Status: Unknown
• Conditions: Neoplasm Metastasis
• Intervention / Treatment: Radiation: Stereotactic Body Radiation Therapy

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Belgium
  • Brussel
    • Jette, Brussel, Belgium, 1090
      • Recruiting
      • UZ Brussel Radiotherapie dienst
      • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
One year local control	one year post radiotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute toxicity		Up to 3 months post radiotherapy
Survival	Overall survival	3 to 36 months post Radiotherapy
Progression Free Survival		3 to 36 months post Radiotherapy
Late toxicity		3 to 36 months post Radiotherapy

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• 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

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: August 22, 2014
• First Submitted That Met QC Criteria: August 26, 2014
• First Posted (Estimate): August 29, 2014

Study Record Updates

• Last Update Posted (Estimate): May 11, 2016
• Last Update Submitted That Met QC Criteria: May 10, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: SBRT; Stereotactic Body Radiation Therapy; IGRT; Neoplasm Metastasis; Image-guided Radiotherapy; oligometastatic cancer; Real-time Tumor Tracking (RTTT); ITV; Internal Target Volume; Respiratory Motion Management
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: BUN143201215117 (Registry Identifier: UZ Brussel Ethics Committee)