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

NCT02228356 | Unknown

• 1 other identifier: BUN143201215117
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• One year local control

  one year post radiotherapy

Secondary Outcomes (4)

• Acute toxicity

  Up to 3 months post radiotherapy

• Survival

  3 to 36 months post Radiotherapy

• Progression Free Survival

  3 to 36 months post Radiotherapy

• Late toxicity

  3 to 36 months post Radiotherapy

Interventions

Stereotactic Body Radiation Therapy RADIATION

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.

Also known as: Vero, Tomotherapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients with metastatic cancer from any primary origin and no more than 5 metastases on CT--scan
• Primary tumor treated with curative intention (surgery, radiotherapy, chemoradiotherapy)
• Functional liver volume \> 1000cc in case of liver metastases and a lung diffusion capacity for carbon monoxide (DLCO) of \> 30% if lung mets
• No Child B or C liver cirrhosis
• No systemic treatment within 1 month before initiation of radiotherapy
• No contra-indications for radiation of all metastatic disease (= no violation of constraints of organs at risk (OAR))
• No metastases from another carcinoma
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Age \> 18 years

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel Radiotherapie dienst

Jette, Brussels Capital, 1090, Belgium

RECRUITING

Related 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.

  PMID: 20685718 BACKGROUND

• 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.

  PMID: 22423615 BACKGROUND

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Radiosurgery; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benedikt Engels, MD, PhD

CONTACT

+324776041; benedikt.engels@uzbrussel.be

Cleo Wauters, MD

CONTACT

+324776041; cleo.wauters@uzbrussel.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: August 22, 2014
• First Posted: August 29, 2014
• Study Start: June 1, 2012
• Primary Completion: June 1, 2017
• Last Updated: May 11, 2016

Record last verified: 2016-05

Locations

BE (1)