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

Neoplasm Metastasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02228356
• Other study ID #: BUN143201215117
• Secondary ID: BUN143201215117
• Status: Recruiting
• Phase: N/A
• First received: August 22, 2014
• Last updated: May 10, 2016
• Start date: June 2012

Study information

• Verified date: May 2016
• Source: Universitair Ziekenhuis Brussel
• Contact: Benedikt Engels, MD, PhD
• Phone: +324776041
• Email: benedikt.engels[@]uzbrussel.be
• Is FDA regulated: No
• Health authority: Belgium: UZ Brussel Ethics Committee
• Study type: Observational

Clinical 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]. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
Belgium	UZ Brussel Radiotherapie dienst	Jette	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	One year local control		one year post radiotherapy	No
Secondary	Acute toxicity		Up to 3 months post radiotherapy	Yes
Secondary	Survival	Overall survival	3 to 36 months post Radiotherapy	No
Secondary	Progression Free Survival		3 to 36 months post Radiotherapy	No
Secondary	Late toxicity		3 to 36 months post Radiotherapy	Yes