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

NCT ID: NCT02228356

Last Updated: 2016-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-30

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.

Conditions

Neoplasm Metastasis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: RADIATION

Other Intervention Names

Vero; Tomotherapy

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Benedikt Engels, MD, PhD

Radiation Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benedikt Engels, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dienst Radiotherapie, UZ Brussel, Vrije Universiteit Brussel

Robbe Van den Begin, MD

Role: PRINCIPAL_INVESTIGATOR

Dienst Radiotherapie, UZ Brussel, Vrije Universiteit Brussel

Mark De Ridder, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dienst Radiotherapie, UZ Brussel, Vrije Universiteit Brussel

Locations

UZ Brussel Radiotherapie dienst

Jette, Brussels Capital, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Benedikt Engels, MD, PhD

Role: CONTACT

benedikt.engels@uzbrussel.be

+324776041

Cleo Wauters, MD

Role: CONTACT

cleo.wauters@uzbrussel.be

+324776041

References

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.

Reference Type: BACKGROUND

PMID: 20685718 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22423615 (View on PubMed)

Other Identifiers

BUN143201215117

Identifier Type: REGISTRY

Identifier Source: secondary_id

BUN143201215117

Identifier Type: -

Identifier Source: org_study_id