Clinical trial NCT02228356: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Image-guided Radiotherapy
IGRT
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2014-08-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic cancer from any primary origin and no more than 5 metastases.

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.


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

Primary outcomes:
measure: One year local control
timeFrame: one year post radiotherapy
Secondary outcomes:
measure: Acute toxicity
timeFrame: Up to 3 months post radiotherapy
measure: Survival
timeFrame: 3 to 36 months post Radiotherapy
measure: Progression Free Survival
timeFrame: 3 to 36 months post Radiotherapy
measure: Late toxicity
timeFrame: 3 to 36 months post Radiotherapy
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel Radiotherapie dienst
state: Brussel
Study officials:
affiliation: Dienst Radiotherapie, UZ Brussel, Vrije Universiteit Brussel
name: Benedikt Engels, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dienst Radiotherapie, UZ Brussel, Vrije Universiteit Brussel
name: Robbe Van den Begin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dienst Radiotherapie, UZ Brussel, Vrije Universiteit Brussel
name: Mark De Ridder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.