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

Study Overview
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Brief Summary
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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.

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

Conditions
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Neoplasm Metastasis

Intervention / Treatment
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* Radiation: Stereotactic Body Radiation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SBRT, Neoplasm Metastasis, oligometastatic cancer, Stereotactic Body Radiation Therapy, Real-time Tumor Tracking (RTTT), ITV, Internal Target Volume, Respiratory Motion Management, Image-guided Radiotherapy, IGRT